MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Arthritis (1723); Atherosclerosis (1728); Bronchitis (1752); Calcium Deposits/Calcification (1758); Cancer, Other (1760); Cyst(s) (1800); Hearing Loss (1882); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Neuropathy (1983); Pain (1994); Rash (2033); Swelling (2091); Urinary Retention (2119); Urinary Tract Infection (2120); Weakness (2145); Burning Sensation (2146); Dizziness (2194); Hernia (2240); Stenosis (2263); Urinary Frequency (2275); Depression (2361); Numbness (2415); Irritability (2421); Confusion/ Disorientation (2553); Hematuria (2558); Limited Mobility Of The Implanted Joint (2671); Dysuria (2684)

Event Type  Injury  

Event Description

On (b)(6) 2002: the patient presented with abdominal pain and underwent ct of abdomen and pelvis with contrast.Impression: markedly distended bladder; atrophic scared right kidney.The patient underwent x-ray of abdomen due to abdominal pain.Impression: benign appearance of the bowel gas pattern at the time of presentation.On unknown date of (b)(6) 2004 patient underwent colonoscopy which showed normal results.On (b)(6) 2005 the patient presented with chief complaints of controlling sugar level.On (b)(6) 2006 the patient presented with complaints of low back pain, flu injection, and right hand swollen.(b)(6) 2006: patient presented after removal of catheter.Patient underwent residual urine ultrasound which revealed approximately 8.8 cc remaining in his bladder after the catheterization was complete which revealed approximately 550 cc.On (b)(6) 2006 the patient presented with complaints of right side pain, flank pain, hyperlipidemia, niddm, low back pain.Assessment: 1.Diabetes mellitus adult onset, new; 2.Combined hyperlipidemia, new; 3.Abdominal pain unspecified, new; 4.Low back pain, unchanged.On (b)(6) 2007 the patient presented with complaints of burning with urination; cloudy urine; follow-up of combined hyperlipidemia; follow-up of diabetes mellitus adult onset; follow-up of low back pain.Assessment: radiculopathy, new; dysuria, new; diabetes mellitus, adult onset, unchanged; combined hyperlipidemia, unchanged; low back pain, unchanged.(b)(6) 2007: patient presented with the issue of burning with urination, cloudy urine and for follow up on back pain and hyperlipidemia.Assessment: radiculopathy, new; dysuria, new; diabetes mellitus adult onset, unchanged; combined hyperlipidemia, unchanged; low back pain, unchanged.(b)(6) 2007: patient presented for follow up on back pain.Assessment: 1.Diabetes mellitus adult onset, unchanged.2.Low back pain, unchanged.3.Radiculopathy, unchanged.On (b)(6) 2007, reportedly, the patient presented with pain, radiculopathy and underwent a lumbar spine mri which demonstrated severe disk space narrowing at l5-s1 (90%) with grade 1 spondylolisthesis.There was marked joint arthrosis combined with the slippage causing severe right and moderate left foraminal narrowing at l5-s1.A radiologic report also showed bilateral pars defects at l5.Impression of mri lumbar spine: there is continuing spondylolisthesis and bilateral pars defects at l5-s1.There is neural foraminal narrowing which is stable.There is marked bladder distention.This study is otherwise stable.(b)(6) 2007: patient presented for follow up mri and blood work, low back pain and diabetes mellitus.Associated symptoms are numbness in thighs.Assessment: 1.Diabetes mellitus adult onset, uncontrolled.2.Low back pain, unchanged.3.Radiculopathy, unchanged.(b)(6) 2007: patient presented for follow up on low back pain and radiculopathy.Associated symptoms are numbness in thighs.Assessment: 1.Low back pain, unchanged.2.Radiculopathy, unchanged.(b)(6) 2007: patient underwent chest x-ray.Impression: no active disease.Patient also underwent audiogram which indicated patient has mild-moderate sensorineural hearing loss in the right ear and mild-moderate predominately sensorineural hearing loss in the left ear.On (b)(6) 2007, per a transaction/billing history, the patient presented with lumbago and underwent a-rays.Imaging studies: ap lateral lumbar x-rays showed a degenerative spondylolisthesis at l5-s1 of 12 m.The patient has severe degenerative disc disease l5-s1.Mri revealed bilateral foraminal stenosis and bilateral pars defects.Diagnosis: 1.Low back pain, 2.Severe degenerative dis disease l5-s1, 3.Isthmic spondylolisthesis l5-s1.On (b)(6) 2007 the patient presented with chief complaints of controlling diabetes.(b)(6) 2007: patient presented with lower back pain.Assessment: hypertension, unchanged; diabetes mellitus, type ii; hyperlipidemia; degenerative disc disease.(b)(6) 2007: patient presented with back pain, hyperlipidemia.Assessment: hypertension, unchanged; diabetes mellitus, type ii; hype rlipidemia; degenerative disc disease; neuropathy, idiopathic peripheral nos.(b)(6) 2007: patient presented with low back pain with numbness, tingling and shooting pain down both legs.Assessment: hypertension, unchanged; diabetes mellitus, type ii; hyperlipidemia; degenerative disc disease; neuropathy, idiopathic peripheral nos.(b)(6) 2007: patient presented for evaluation of cardiovascular risk.Per doctor, patient¿s left axillary discomfort is highly atypical and probably not a manifestation of myocardial ischemia.(b)(6) 2007: patient underwent spect myocardial perfusion study due to chest discomfort and hypertension.Conclusion: probably normal study.Patient also underwent adenosine myoview stress test.Results: 1.Negative stress ecg for myocardial ischemia; 2.Stable hemodynamic response to adenosine; 3.No significant arrhythmias notes.(b)(6) 2007: patient presented for follow up after completing an additional carotid duplex.On (b)(6) 2007 the patient presented with stenosis, spondylosis and laminectomy with interbody fusion l5-s1.The patient presented for pre-surgical evaluation for the l5-s1 spondylolisthesis reduction and laminectomy with interbody fusion l5-s1.It was reported that the patient suffered from severe nausea after anesthesia and also had issues with his bladder.Medications given: percocet and vistaril.(b)(6) 2007: patient presented for follow up on lab results and diabetes.Assessment: hypertension, unchanged; diabetes mellitus, type ii; hyperlipidemia; degenerative disc disease; neuropathy, idiopathic peripheral nos; long term medication use.On (b)(6) 2007 the patient presented with pain and the preoperative diagnosis of spondylolisthesis with spinal stenosis.The patient underwent l5 bilateral laminectomies with foraminotomies and complete inferior facetectomies; transforaminal lumbar interbody fusion, l5-s1; peek-capstone interbody fusion, l5-s1; posterior spinal fusion, l5-s1; posterior spinal instrumentation with 3d and mpa screw/rod construct; morsellized autograft bone graft; bone morphogenic protein sponge preparation and application; and a spondylolisthesis reduction.Per the operative report, a complete discectomy was carried out through the transforaminal approach on the left side and a medium infuse set was mixed.All four sponges we placed into the interbody space.A peek-capstone interbody fusion cage was chosen and impacted into position.Additional morsellized autograft bone was place around it as well.After this was accomplished, the area was vigorously irrigated.Morsellized was placed posterolateral for the arthrodesis at l5-s1.The left screws were placed at l5 and s1 and the spondylolisthesis was fully and completely reduced.This was then looked into compression and lock nuts were popped off.No patient complications were reported.On (b)(6) 2007 per billing records, the patient underwent x-rays of the chest.Impression: unremarkable portable chest.Patient presented for follow up on leg pain.Neuro examination revealed muscle weakness and abnormal gait.Psychological examination revealed subdued effect, depressed mood and tearful.Assessment: confusion; hypertension, unchanged; diabetes mellitus, type ii; hyperlipidemia; degenerative disc disease; neuropathy, idiopathic peripheral nos; long term medication use; urinary retention.On (b)(6) 2007 the patient underwent 2 views of the lumbar spine.Impression: no evidence of acute injury to the lumbar spine in the patient was status post fixation of the l5-s1 vertebral bodies.On (b)(6) 2007 the patient presented with primary diagnoses of 1.Back pain status post lumbar fusion surgery; 2.Hypertension; 3.Diabetes.The patient presented for physical examination.Assessment: lower back pain status post lumbar fusion surgery; diabetes mellitus; hypertension; pain management needed; urinary retention.The patient was discharged and the discharge condition was stable.(b)(6) 2007: patient presented with primary diagnoses of epididymoorchitis and testicular pain.Impression: 1.Left epididymal orchitis.2.Urinary retention, probably secondary to neurogenic bladder and the recent back surgery.3.Weight loss.On (b)(6) 2007 the patient presented with continuing improvement.Per a transaction/billing history, the patient underwent x-rays.Ap lateral radiographs showed that he was fusing at l5-s1.(b)(6) 2007: patient presented post lumbar surgery with complaints of radiculopathy, numbness in feet, neuropathic pain.Assessment: confusion; hypertension, unchanged; diabetes mellitus, type ii; hyperlipidemia; degenerative disc disease; neuropathy, idiopathic peripheral nos; long term medication use; urinary retention.(b)(6) 2008: patient presented with back pain and episodes of tearful mood.Assessment: hypertension, unchanged; diabetes mellitus, type ii; hyperlipidemia; neuropathy, idiopathic peripheral nos; long term medication use; back pain; insomnia.(b)(6) 2008: patient presented with rashes and burning pain to lateral side of left leg and tops of his feet, depression and unpredictable episodes of crying.Assessment: back pain; hyperlipidemia; hypertension; diabetes mellitus, type ii; neuropathy, idiopathic peripheral nos; long term medication use; dermatitis; insomnia.On (b)(6) 2008 the patient presented with diagnosis of low back pain and lumbar arthritis.Assessment: generalized and core weakness secondary to inactivity and disuse.Muscular and neural tension in bilateral lower extremities.(b)(6) 2008: patient presented with cough and congestion, shaking chills and discolored phlegm which is very tenacious.Patient also reported nausea.Assessment: back pain; hyperlipidemia; hypertension; diabetes mellitus, type ii; neuropathy, idiopathic peripheral nos; long term medication use; sinusitis; bronchitis; insomnia.(b)(6) 2008: patient presented with numbness to the right foot, which has now extended to the little tow and it radiated up the leg.Neuro examination revealed abnormal gait.Assessment: neuropathy, idiopathic peripheral nos; long-term medication use; diabetes mellitus, type ii; back pain; hyperlipidemia; hypertension; urinary retention.On (b)(6) 2008, approx.Six mo.Post op, the patient presented with 2nd, third, and small toe numbness, pain in foot, and sleep disturbance secondary to pain.The patient reported back improvement.Diagnostic data: ap and lateral lumbar x-rays demonstrated no loosening of instrumentation.Disc space was unchanged above his fusion since prior x-ray.Diagnosis: six months status post l5-s1 transforaminal lumbar interbody fusion and posterior spine fusion.(b)(6) 2008: patient presented with abdomen and right flank pain.Patient underwent ct abdomen/pelvis without contrast due to pain stone.Impression: continued distended urinary bladder which could be due to bladder outlet obstruction, neurogenic or atomic bladder.Deformed mid and lower pole of the right kidney with a stable 3 mm perinephric calcification.Distention of the right collecting system felt to be secondary to a 4 mm calculus at the right upj in a similar location to the prior stone obstruction.3 cm cyst stable in the left kidney.(b)(6) 2008: patient presented with right renal colic related to 4 mm upj stone, increased hematuria with clots.(b)(6) 2008: patient presented with back and neck injury, diabetes and ¿hbp¿.(b)(6) 2008: patient presented with toes being numb.Spine examination revealed reduced mobility.Assessment: back pain; hypertension, unchanged; diabetes mellitus, type ii; hyperlipidemia; dermatitis; insomnia; neuropathy, idiopathic peripheral nos; long term medication use; degenerative disc disease.On (b)(6) 2008 the patient underwent ct lumbar spine w/contrast.Impression: post surgical changes are seen at the l5-s1 level.There is increase in soft tissue density identified in the anterior extradural space.This is eccentric being more pronounced on the right.The finding most likely represents epidural fibrosis.Focal disc herniation can not be completely excluded but not seen with certainty.Mild disc bulging and ligamentum flavum hypertrophy is developing at the l4-5 level.This does not significantly encroach upon the central canal or neural foramina.The upper lumbar area appears within normal limits.(b)(6) 2008: patient underwent myelography lumbosacral due to low back pain.Impression: no definite nerve root sleeve cut off is identified.On (b)(6) 2008 the patient presented with low back and significant burning and numbness in the right lower extremity especially in the right dorsal foot.Assessment: lumbago-greatly improved; lumbar disc degeneration; lumbar spondylosis; post laminectomy syndrome (lumbar) s/p l5-s1 fusion without complication; lumbar radiculopathy-clinically right l5 9 epidural fibrosis at l5-s1).(b)(6) 2008: patient presented for follow up after myelogram with nerve pain in right leg.Spine examination revealed reduced mobility.Assessment: back pain; hypertension, unchanged; diabetes mellitus, type ii; hyperlipidemia; sinusitis; bronchitis; cough; neuropathy, idiopathic peripheral nos; long term medication use; degenerative disc disease; exposure to communicable disease.On (b)(6) 2008 the patient presented with low back and right lower extremity pain with burning and numbness.Medications: lyrica, vi coprofen, vicodin, flexeril.Assessment: lumbago-greatly improved; lumbar disc degeneration; lumbar spondylosis; post laminectomy syndrome (lumbar) s/p l5-s1 fusion without complication; lumbar radiculopathy-clinically right l5 9 epidural fibrosis at l5-s1).(b)(6) 2009: patient presented with chest congestion and cough.Spine examination revealed reduced mobility.Assessment: back pain; hypertension, unchanged; diabetes mellitus, type ii; hyperlipidemia; sinusitis; bronchitis; cough; neuropathy, idiopathic peripheral nos; long term medication use.(b)(6) 2009: patient presented for follow up.(b)(6) 2009: patient presented with ¿dm¿, low back pain, dyslipidemia.Assessment: low back pain; weakness of right lower extremity; dm; dyslipidemia.Patient underwent alcohol screening, depression screening, ptsd screening, tobacco use screening.(b)(6) 2009: patient presented with depressive symptoms, anxiety.Patient underwent suicide risk assessment.(b)(6) 2009: patient presented with chief complaint of urinary frequency and burning on urination, dysuria.(b)(6) 2009: patient presented with issues of depression.Patient underwent suicide risk assessment.Diagnosis: axis i.Depressive d isorder, nos; ptsd.Axis iv.Chronic pain, recent retirement.On (b)(6) 2009 the patient presented with complaints of dm, low back pain and dyslipidemia.Assessment: 1.Low back pain ¿ patient has undergone surgery in the past , patient has some weakness of the right lower extremity; 2.Dm ¿ on metformin and glipizide ¿ medications refilled; 3.Dyslipidemia ¿ on treatment ¿ medications refilled.On (b)(6) 2009 the patient presented with complaints of urinary frequency and burning on urination.On (b)(6) 2009 the patient complains of left rib pain after reaching into the window until he heard a pop on his left side.The patient underwent x-rays of ribs unilat 2 views (left) due to rib pain.Impression: pa examination of the chest shows heart was normal size with artherosclerotic changes seen.Lungs show no evidence of an acute infiltrate or pneumothorax.Four views of the left ribs show no evidence of acute fracture.There was slight deformity of the left 10th rib anteriorly at the region of the costal cartilage most probably developmental in origin.Degenerative changes were seen in the thoracic spine.(b)(6) 2009: patient presented with injured ribs and left lower rib pain after running into a blunt edge of window.(b)(6) 2009: patient presented for evaluation of removal of a lipoma over the right themar eminence.(b)(6) 2009: patient presented with depression at times, feeling of sadness and emotional.Patient would cry and get angry.On (b)(6) 2010 the patient presented with complaints of pain in lower back, pain in the left posterior thigh just below the buttock and pain over the lateral aspects of each thigh.Impression: chronic lower back pain and s1 radiculopathy; history of l5,s1 transforaminal interbody fusion and posterior spine fusion; sensory changes in the right foot/toes; type 2 diabetes mellitus; hypertension; hypercholesteremia; depression/ptsd.On (b)(6) 2010 the patient underwent x-rays of hand 1 or 2 views (right) due to growth over the right thenar eminence.Impression: 3 views of the right hand show mild degenerative changes of the first metacarpal phalangeal joint and interphalangeal joint of the thumb as well as the distal interphalangeal joints of the rest of the digits.On (b)(6) 2010 the patient presented for hand surgery consult.Impression: 1.Mass of the right thenar area; 2.Mild dupuytren¿s cont racture.On (b)(6) 2010 the patient underwent x-rays of chest 2 views pa and lat pre-op.Impression: pa and lateral chest, the heart, lungs, mediastinum and osseous structures were unremarkable.No infiltrate, effusion, consolidation, cavitary lesion or congestive change.No acute pulmonary process.Trachea was in the midline.Hilar regions were unremarkable.Conclusion: negative chest.Anterior cervical screw-plate lower cervical spine.On (b)(6) 2010 the patient presented with complaints of elevated blood sugar.Assessment: dm.On (b)(6) 2010 the patient presented with chief complaints of blood in urine, including clots.The patient underwent x-rays of abdomen 1 view due to history of stone and hematuria.Impression: small calcific density seen to the right of the right l5 transverse process of uncertain significance, but felt to most likely represent enteric content as it was seen on only one view.Calcific density over the right lower quadrant of uncertain significance, possibly representing an enterolith, to include appendicolith.If there was persistent clinical concern for stone or symptoms of obstructive uropathy then consider ct for further evaluation.On (b)(6) 2010 the patient presented with chief complaints of right flank pain and hematuria.The patient underwent ct of abdomen without contrast due to hematuria and flank pain.Impression: 1.The right renal and ureteral collecting system was duplicated.Severe hydroureteronephrosis of the lower pole moiety of the right kidney and lower pole ureter.There was severe tortuosity of the distal ureter prior to the insertion into the urinary bladder.No renal or ureteral calculi were seen.This may be due to reflux due to severely distended urinary bladder.2.Severely distended urinary bladder.There was a thickened wall of the urinary bladder measuring up to 1.1 cm.These findings can be seen with chronic outlet obstruction, such as with an enlarge prostate, cystitis, or neurogenic bladder.Clinical correlation was recommended.3.Status post cholecystectomy 4.Enlarged prostate gland.Clinical correlation and psa was recommended.On (b)(6) 2010 the patient presented for urology consult.Assessment: inflamed versus infected subcutaneous scrotal wall cyst.However, patient may have an additional cyst deeper in wall; acute bronchitis; diabetes.(b)(6) 2003: patient underwent ct of pelvis and abdomen with contrast.Impression: there appears to be a duplicated collecting system on the right kidney.1.There is a cortical atrophy and dilation of the renal collecting systems of the lower pole moiety with dystrophic calcifications seen in the renal pelvis which may represent staghorn-type calcifications.The process appears chronic.2) there is a large mass extending 17x14x16 cm.The mass measures approximately 22 houndsfield units.This may represent a markedly distended bladder, cyst arising from the mesentery or possibly a urachal cyst.3) small ventral midline hernia without evidence for obstruction.4) a 2 cm low density lesion seen in the anterior left mid kidney probably representing a cyst but not adequately characterized by this study.(b)(6) 2003: patient underwent ct of pelvis with contrast.Impression: marked distension of the urinary bladder raising the possibility of neurogenic bladder; a 1.8cm probable cyst in the mid-portion of the left kidney; no other significant interval change is seen, including partial duplication of the right kidney, and small midline ventral hernia.(b)(6) 2005: patient presented for the evaluation of frequent urination and complaints of some lower pressure.Assessment: chronic low back pain; dysuria.(b)(6) 2005: patient presented for medication refill.Assessment: back pain; sleep disturbances; diabetes; hypertension.(b)(6) 2005: patient presented for the evaluation of low back pain, this is a chronic and recurring condition.(b)(6) 2005: patient presented for evaluation of low back pain and refills on his medication.Assessment: chronic low back pain.(b)(6) 2005: patient presented for medication refill.Assessment: upper respiratory infection; diabetes; hypertension; back pain.(b)(6) 2006: patient presented with complaint of ear pain and diminished hearing.Assessment: cerumen impaction 380.4 (b)(6) 2006: patient presented for medication refill; assessment: back pain.(b)(6) 2006: patient presented for evaluation of congestion, coughing and not sleeping well.Assessment: upper respiratory infection; insomnia; chronic back pain.(b)(6) 2006: patient presented for follow-up of his low back pain.Assessment: low back pain; diabetes; hypertension.(b)(6) 2006: the patient presented with complaint of cough, congestion and some itchiness.Assessment: allergic rhinitis; back pain; diabetes; hypertension.(b)(6) 2006: patient presented for the evaluation of blister he had developed and redness on the back of his right heel.Patient stated he has developed rash around his groin area.And also he had stomach upset and chronic back pain.Assessment: cellulitis, right heel; back pain; tinea cruris.(b)(6) 2006 patient presented with a complaint of requesting prescription refills.Assessment: diabetes mellitus; hypertension; hype rlipidemia.(b)(6) 2006 patient presented for evaluation of rash.Assessment: atopic dermatitis.(b)(6) 2006: patient presented with complaint of some itching all over.He had some little mite bites all over.Assessment: dermatitis; back pain; asthama; sleep disturbance.(b)(6) 2006: patient presented with low back pain.Assessment: lumbar strain 847.2.(b)(6) 2006: patient presented for medication refill.Assessment: chronic back pain; diabetes mellitus.(b)(6) 2006: patient presented for multiple medication refill and also with a complaint of reoccurrence of his rash.The rash is pruritic and located on his upper extremities as well on his abdomen and his waist area.Assessment: hypertension; type ii diabetes; history of chronic back pain.(b)(6) 2006: patient presented for medication refill, and also states that he has a chronic back pain.Assessment: chronic back pain; insomnia; diabetes.(b)(6) 2006 patient presented with complaint of painful skin irritation on the left upper thigh and right antecubital space.Assessment: herpes zoster- left upper thigh; atopic dermatitis.(b)(6) 2007: patient presented with a complaint of urgency and frequency of urination and cloudy urination.Assessment: urinary tract infection; diabetes; hypertension; hyperlipidemia.(b)(6) 2007: patient presented for medication refill.Assessment: hypertension; hyperlipidemia; diabetes mellitus.(b)(6) 2007: patient presented with dysuria.Patient also stated that for about three or four days, he has had a pain with urination, hesitancy and increased frequency.Assessment: urinary tract infection.(b)(6) 2007: patient presented with a complaint of right shoulder pain and right thoracic pain.Patient was involved in motor vehicle accident on (b)(6).Assessment: somatic dysfunction thoracic area.(b)(6) 2007 the patient underwent x-ray of right shoulder.Impression: right shoulder is within normal (b)(6) 2007 patient presented for medication refill.Assessment: diabetes; chronic back pain.(b)(6) 2007: patient presented for evaluation of low back pain.This chronic condition.Assessment: diabetes; back pain; hyperlipidemia.(b)(6) 2007 patient presented with requesting a refill on his ambien and xanax.Patient states that he is becoming anxious and not sleeping well.Assessment: chronic back pain, anxiety, insomnia.(b)(6) 2007 patient presented for multiple medication refills.Assessment: history of hypertension; type ii diabetes; chronic low back pain.(b)(6) 2014 the patient presented with back pain radiating to legs.Impressions: positive slr bilaterally.Low back tenderness to palpation.Muscle spam noted.Assessment: degenerative lumbar disc disease.

Event Description

It was reported that the patient underwent a transforaminal lumbar interbody fusion procedure at l5-s1 using rhbmp-2/acs on (b)(6) 2007.Post-operatively in 2008, patient was diagnosed with significant bone overgrowth and a cyst at the site of the fusion.

Manufacturer Narrative

(b)(4): neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2004, reportedly, the patient underwent a cardiac risk profile.On (b)(6) 2005 the patient presented with worsening abdominal pain which the patient stated began several years prior.The pain was described as in the midline abdominal incisional area with a burning and cramping quality.Per the encounter notes it was aggravated by previous hernias with mesh in place.Assessment: new ventral and incisional hernias.On (b)(6) 2005, in a telephone encounter, the doctor reported that the patient's sugar was worse than ever.: on (b)(6) 2005 the patient presented with recurrent incisional hernia and underwent a surgical repair.On (b)(6) 2005 it was noted that the patient was post op repair of a large recurrent incisional hernia.The staples and rains were removed from the wound.On (b)(6) 2005 the patient presented with a "fair amount of swelling" which was believed to be a seroma fluid accumulation.On (b)(6) 2005 per the encounter notes, it stated that the patient physically had a very large seroma fluid collection in the subcutaneous space that they believed would resolve spontaneously.It was also noted that a ct had shown no sign of recurrent hernia.On (b)(6) 2005 the patient presented with low back pain radiating into the bilateral legs with numbness.On (b)(6) 2005 the patient presented with low back pain radiating into the bilateral legs with numbness.On (b)(6) 2006 the patient presented with low back pain radiating into the bilateral legs with numbness.The patient reported having had laminectomy years before.Medications: motrin and vicodin.Between (b)(6) 2006 and (b)(6) 2007 the patient presented for multiple physical therapy sessions with lower back and radicular leg pain.On (b)(6) 2006 the patient presented with moderate itching /rash.Assessment: scabies.On (b)(6) 2006 the patient presented with lower back pain radiating into bilateral legs.The patient reported that the pain had begun years prior.On (b)(6) 2006 the patient presented with right hand swelling with itching rash; a moderate rash on head, arms, face and groin; and new - urticarial, uncontrolled diabetes mellitus ii.Medications: medrol does pak, betamethasone, and vioprofen.On (b)(6) 2006 the patient presented with low back pain.On (b)(6) 2006, reportedly, the patient presented in er with acute right flank pain.On (b)(6) 2006 the patient presented with acute right flank pain with hydronephrosis and duplicate system on the right.Per the encounters notes a ct scan had shown 3 stones in the right upj area.The patient underwent a cystoscopy which revealed no obstructions.No patient complications were noted.On (b)(6) 2007, reportedly, the patient presented with pain and underwent a lumbar spine mri which demonstrated severe disk space narrowing at l5-s1 (90%) with grade 1 spondylolisthesis.There was marked joint arthrosis combined with the slippage causing severe right and moderate left foraminal narrowing at l5-s1.A radiologic report also showed bilateral pars defects at l5.On 11 april 2007 the patient presented worsening low back pain which was reported as having been ongoing on and off for the past 20 years after his cervical fusion.The patient had numbness going down both lateral thighs, aching in calves, constant aching and numbness in buttocks, occasional pain shooting into the left leg, aching numbness and tingling in legs, and restless legs.Impression: low back pain, pars defect l5, isthmic spondylolisthesis, grade 1, severe degenerative disc disease at l5-s1, bilateral femoral narrowing, l5-s1, multilevel z joint arthrosis, and bilateral sciatica.Medications: vicoprofen.On (b)(6) 2007, per a transaction/billing history, the patient presented with lumbago and underwent a-rays.On (b)(6) 2007 the patient presented with progressively worsening low back and bilateral leg pain, right > left and sleep disturbances secondary to pain.On (b)(6) 2007 the patient presented with severe back and leg pain with spondylolisthesis and spinal stenosis at l5-s1.On 18 aug 2007 the patient presented with lower back pain.On (b)(6) 2007 the patient underwent an ecg which was normal.On (b)(6) 2007 the patient underwent a myoview stress test which revealed no myocardial ischemia and a normal left ventricular ejection fraction.On (b)(6) 2007 the patient presented with stenosis and spondylosis.On (b)(6) 2007 the patient presented with neuropathy, diabetes mellitus type 2, and hyperlipidemia.The patient underwent labs which revealed high cholesterol levels.A urinalysis showed abnormal specific gravity and glucose levels.Medications: vicodin.On (b)(6) 2007, per a transaction/billing history, the patient presented in an office visit with lumbago.On (b)(6) 2007 the patient underwent a chest x-rays which showed a negative chest and degenerative disc change in the dorsal spine and post cervical changes at the cervicothoracic junction.On (b)(6) 2007 the patient presented with pain and the preoperative diagnosis of spondylolisthesis with spinal stenosis.The patient underwent l5 bilateral laminectomies with foraminotomies and complete inferior facetectomies; transforaminal lumbar interbody fusion, l5-s1; peek-capstone interbody fusion, l5-s1; posterior spinal fusion, l5-s1; posterior spinal instrumentation with 3d and mpa screw/rod construct; morcellized autograft bone graft; bone morphogenic protein sponge preparation and application; and a spondylolisthesis reduction.Per the operative report".A complete discectomy was carried out through the transforaminal approach on the left side and a medium infuse set was mixed.All four sponges we placed into the interbody space.A peek-capstone interbody fusion cage was chosen and impacted into position.Additional morcellized autograft bone was place around it as well."no patient complications were reported.On (b)(6) 2007, post op one day, the patient presented with low back pain, high blood pressure and poorly controlled diabetes.On (b)(6) 2007 the patient presented with urinary retention, constipation, hypertension, and high blood sugar (poorly controlled diabetes mellitus).The patient reported that they had self-catheterized themselves after the surgery and were being followed by an urologist for this.On (b)(6) 2007 the patient was discharged from hospital.On (b)(6) 2007 telephone encounter, it was reported that the patient had severe right leg pain radiating from buttocks to ankle.On (b)(6) 2007, approx.2 week post op, the patient presented with improved left leg and lower back symptoms.Diagnosis: lumbago, sciatica, lumbar spinal stenosis and spondylolisthesis.On (b)(6) 2007 telephone encounter, it was reported that the patient was overmedicated, not eating and still in severe pain.On (b)(6) 2007, approx.4 week post op, the patient presented with severe bilateral leg pain "different than the pain he had prior to operating room".Medications: neurontin, vistaril, oxycontin, valium, keflex, and lortab.Diagnosis: spondylolisthesis.On (b)(6) 2007 it was reported that the patient was admitted to er for severe concussion.In a telephone encounter the same day, it was reported that the patient was not doing very well.That the patient was had leg pain and sensitivity and was showing signs of confusion which was felt to be due to the medication.On (b)(6) 2007 the patient presented with aching in legs at night.It was noted that the patient's urinary symptoms had resolved.Medications: oxycontin and valium.On (b)(6) 2007 telephone encounter, it was reported that the patient was in severe pain and unable to get around very well.On (b)(6) 2007 telephone encounter, it was reported that the patient had to be hospitalized due to a testicular infection "because he had decided to stop cathing himself".On (b)(6) 2007 the patient presented with continuing improvement.Per a transaction/billing history, the patient underwent x-rays.On (b)(6) 2007, per a transaction/billing history, the patient presented in an office visit with lumbago, spondylolisthesis, cervical degenerative disease, and spinal stenosis.On (b)(6)2008 the patient presented with continuing left leg pain and improved lower back.The patient reported that lyrica was not helping much and they wanted to try "oxycontin patch".On (b)(6) 2007, per a transaction/billing history, the patient presented in an office visit with lumbago, spondylolisthesis, cervical degenerative disease, and spinal stenosis.On (b)(6) 2008 the patient presented with" "doing great" -"no pain".Lumbar x-rays showed l5-s1 fused.Between feb (b)(6) 2008 the patient presented for multiple physical therapy sessions with lower back pain: lumbago.On (b)(6) 2008 the patient presented with improved pain.In a notation, it referenced that the patient had been given a tens unit for use.On (b)(6) 2008 the patient was given the diagnosis of low back pain and lumbar arthritis.On (b)(6) 2008, per a transaction/billing history, the patient had undergone surgery for removal of spinal fixation and exploration of fusion.On (b)(6) 2008 the patient presented with numbness in the left foot toes.The patient underwent an emg and nvc testing which demonstrated axonal motor peroneal right and let minimal decrease in conduction velocity.On (b)(6) 2008, approx.Six mo.Post op, the patient presented with 2nd, third, and small toe numbness, pain in foot, and sleep disturbance secondary to pain.The patient reported back improvement.On (b)(6) 2008 the patient presented with low back and significant burning and numbness in the right lower extremity especially in the right dorsal foot.The patient walked with an altered gait and reported lack of sensation in the foot.The patient reported that since their surgery they had improved lower back pain but only partial relief of the lower extremity pain/paresthesias and now it was getting worse.On (b)(6) 2008 the patient presented with numbness in the 4th and fifth toes and leg cramping.On (b)(6) 2008 the patient presented with pain and underwent a ct myelogram which demonstrated postsurgical changes at l5-s1; an increase in the soft tissue density identified in the anterior extradural space which was eccentric - being more prominent on the right; these finding were most likely representative of epidural fibrosis, but focal herniation could not be excluded.There was mild disc bulging and ligamentum flavum hypertrophy developing at l4-5 which did not significantly encroach upon the central canal or neural foramina.A lumbar spine ct with contrast showed l3-4 and l4-5 showed minimal to mild disc bulge and ligamentum hypertrophy.At l5-s1 there was a loss of disc height of the intervertebral disc space with minimal anterior listhesis of l5 on s1.There was an increase in soft tissue density in the anterior extradural space, right > than left.On (b)(6) 2008 the patient presented with right foot 4th and 5th toe numbness, numbness of the dorsum of foot and cramping in the lower leg.On (b)(6) 2008 the patient presented with low back and significant burning and numbness in the right lower extremity especially in the right dorsal foot.On (b)(6) 2008 the patient presented with low back and right lower extremity pain with burning and numbness.Medications: lyrica, vi coprofen, vicodin, flexeril.On (b)(6) 2009 the patient presented with low back and right lower limb pain.The patient has significant burning and numbness in the right lower extremity especially in the right dorsal foot.Medications: vicoprofen and flexeril.Assessment: lumbago, lumbar disc degeneration, lumbar spondylolisthesis, post laminectomy syndrome, and lumbar radiculopathy.Prescribed: amrix for radiculopathy.On (b)(6) 2014 the patient presented with radiculitis and degenerative disc disease.

Manufacturer Narrative

Review of radiographic images found as follows: (b)(6) 2007 lumbar mri grade one isthmic spondylolisthesis with advanced degenerative disc arthritis, anterior herniation and foraminal stenosis at l5.Mild desiccation noted at l2.Small hemangioma noted at pedicle of l2 on the left.Axial views verify absence of central stenosis consistent with isthmic spondylolisthesis.Foraminal stenosis is noted bilaterally affecting both l5 roots.(b)(6) 2007 us carotid doppler, no comment.(b)(6) 2007 lumbar spine series open tlif has been performed at l5/s1.Under penetration prevents view of disc space.(b)(6) 2008 lumbar myelogram no nerve compression appreciated.(b)(6) 2008 ct lumbar with contrast shows heterotopic bone that has developed in the track through which the capstone was placed.This is on the left at the l5 disc level.There are lytic holes within the heterotopic bone and the affect could place compression/displacement upon the left l5 and s1 roots.(b)(6) 2011 lumbar mri interval tlif has been performed since last mri at l5/s1.Fusion is solid.Fusion appears to have been in situ as grade one spondy persists.Abundant scar is seen in midline behind screws.Position of screws is satisfactory.Capstone is eccentric to the left, the side through which it was placed.

Manufacturer Narrative

(b)(4).

Event Description

(b)(6) 2007, (b)(6) 2007: the patient presented with diagnoses of spondylolisthesis, ddd and underwent l5-s1 interlaminar procedure.(b)(6) 2012: the patient presented with right sided flank pain and burning with urination.Patient's urinalysis demonstrated significant hematuria and pyuria.Ct scan showed bilateral hydronephrosis primarily within the lower pole of the right kidney and moderate hydronephrosis of the left kidney.On (b)(6) 2012 the patient presented complaining of blood in urine.The patient presented for ct abd/pelvis w/o contrast for stone protocol, flank pain.Impression: unchanged bilateral hydronephrosis and ureterectasis, severe on the right.Marked bladder distention and diffuse bladder wall thickening is also unchanged; duplicated right renal collecting system.On (b)(6) 2012 the patient presented for er follow up.Assessment: ac pyelonephritis-resolved; type ii diabetes; hyperlipidemia; hypertension nos; post traumatic stress disorder.On (b)(6) 2012 the patient presented for urinary symptoms.Assessment: urinary tract infection; dysuria; urinary frequency.On (b)(6) 2012 the patient presented for type ii diabetes follow up.Assessment: type ii diabetes; hyperlipidemia; hypertension; osteoarthrosis unsp oth sites; other anomalies kidney.On (b)(6) 2012 the patient presented complaining incomplete emptying, ed.Impression: luts, ed, urinary retention.On (b)(6) 2012 the patient presented for type ii diabetes follow up.Assessment: type ii diabetes; hyperlipidemia; hypertension; urinary tract infection unspec.On (b)(6) 2012, (b)(6) 2012, (b)(6) 2012 the patient presented for type 2 diabetes follow up.Assessment: type ii diabetes; hyperlipidemia; hypertension.On (b)(6) 2012 the patient presented for back pain follow up.Assessment: low back pain; radicular low back pain; lumbar disc degene ration; osteoarthrosis unsp oth sites; impacted cerumen; acute sinusitis unspecified.(b)(6) 2012: the patient presented with left ear pain and left facial numbness.The patient underwent ct scan of the head/brain without contrast.Impression: there has benn no significant interval change.No bleed, shift or mass effect.On (b)(6) 2012 the patient presented for back pain follow up.Assessment: low back pain; type ii diabetes; osteoarthrosis unsp oth s ites; hyperlipidemia; hypertension nos; lumbar disc degeneration; glossitis.On (b)(6) 2012 the patient presented for follow up.Assessment: lumbago; radicular low back pain; lumbar disc degeneration; type ii diabetes; hyperlipidemia; hypertension nos; swelling/mass/lump in head/neck.On (b)(6) 2012 the patient presented for back pain follow up.Assessment: type ii diabetes; hyperlipidemia; hypertension; lumbar disc degeneration; unspecified otitis media.(b)(6) 2012: the patient presented with right lower jaw swollen and dental pain on left lower tooth.The patient underwent ct scan of the maxillofacial area.Impression: 1.Diffuse infiltration of the subcutaneous fat of the right cheek suggestive of cellulitis.2.Multiple dental caries.On (b)(6) 2012 the patient presented for er follow up.Assessment: type ii diabetes; osteoarthrosis unsp oth sites; hyperlipidemia; hypertension nos; lumbar disc degeneration; periapical abscess wo sinus.(b)(6) 2014: the patient presented to the er with the complaints of having some constipation, cloudy urine and burning sensation in urine.The ct scan of the abdomen and pelvis done showed massive enlargement of the urinary bladder with air-fluid level.Extensive gas within the wall of urinary bladder and both ureters consistent with pyogenic urinary tract infection with probable necrotizing cystitis.Impression: 1.Pyogenic urinary tract infection with probable necrotizing cystitis.2.Status post recent orchitis and orchiectomy 3.Hyponatremia 4.Uncontrolled diabetes 5.Hypertension 6.Chronic back pain 7.Hyperglycemia.On (b)(6) 2014 the patient presented for annual wellness.Assessments: unspecified general medical examination; hypertension essential, unspecified, loss of weight; diabetes mellitus without mention of complication, type ii or unspecified type, not stated as uncontrolled; other and unspecified hyperlipidemia; thoracic or lumbosacral neuritis or radiculitis, unspecified, osteoarthrosis, unspecified whether generalized or localized, other specified sites; degeneration of lumbar or lumbosacral intervertebral disc; post traumatic stress disorder; major depressive disorder, recurrent episode, moderate; personal history of malignant neoplasm of testis; personal history of other congenital malformations.On (b)(6) 2014 the patient presented for assessment of temazepam and go over glucose labs.Assessments: diabetes mellitus without mention of complication, type ii or unspecified type, not states as uncontrolled; other and unspecified hyperlipidemia; thoracic or lumbosacral neuritis or radiculiits, unspecified; impotence of organic origin; anxiety state, unspecified.On (b)(6) 2014 the patient presented for testosterone.Assessments: impotence of organic origin.On (b)(6) 2014 the patient presented with chronic pain.Assessments: thoracic or lumbosacral neuritis or radiculiits, unspecified, d egeneration of lumbar or lumbosacral intervertebral disc; impotence of organic origin; anxiety state, unspecified.On (b)(6) 2014 the patient presented with radiculitis and degenerative disc disease.(b)(6) 2014: the patient presented complaining of right side abdominal pain and onset blood in urine.The patient underwent ct scan of the abdomen and pelvis due to stone protocol and flank pain.Impression: there is severe distention of the urinary bladder.The bladder extends superiorly above the level of the umbilicus.The bladder is irregularly thick walled.No calculus.Previously noted gas associated with the renal collecting system has resolved.There is severe hydronephrosis of the lower pole moiety of the duplicated right kidney with severe right-sided hydronephrosis.Mild hydronephrosis of the upper pole of the right kidney, as well as hydronephrosis of the left renal collecting system.There is moderate left-sided hydro ureter present.Circumferential rectal wall thickening versus under distention.No free fluid or free air.(b)(6) 2014: the patient presented with hematuria and right flank pain.The patient underwent radionuclide renal scan due to hematuria.Impression: slightly diminished perfusion in the left kidney with relatively symmetric contribution to gfr bilaterally.There is decreasing activity in the collecting systems over time, consistent with no significant obstructive change.Negative for significant response to lasix.The cat scan of the abdomen and pelvis without contrast showed severe displacement of the urinary bladder above the level of umbilicus; thickened walls; no stone; bilateral hydronephrosis.(b)(6) 2014: the patient presented with flank pain, hematuria, and nausea.He also complained of right abdomen pain radiating to lower back and reported painful urination.Three way foley catheter was placed and irrigation was performed.The patient's pain was resolved.Lab results were unremarkable except for an elevated glucose.Assessments: gross hematuria, lumbago; thoracic or lumbosacral neuritis or radiculitis, unspecified; abdominal pain, right upper quadrant; diabetes with other specified manifestations, type ii or unspecified type, not stated as uncontrolled; personal history of malignant neoplasm of testis; insomnia, unspecified.(b)(6) 2014: the patient presented in er with right flank pain.He also stated blood was back in urine and pain in right upper belly.Assessment: 1.Possible right pyelonephritis 2.Type 2 diabetes 3.Hypertension 4.Chronic hyponatremia 5.Hypercholesterolemia 6.Chronic back pain.(b)(6) 2014: the patient presented with uti which was reported as recurrent came in along with fever and right flank pain.The patient underwent ultrasound study of the retroperitoneal aorta node due to right pyelonephritis compared with the ct scan study from (b)(6) 2014.Impression: apparent duplication of the right renal collecting system with pronounced hydronephrosis of the lower pole moiety and mild dilation of the upper pole moiety.There is dilation of the distal right ureter demonstrated.Distended thick walled urinary bladder.Left renal cyst.Assessment: 1.Urinary tract infection with suspected right pyelonephritis with cerebrovascular tenderness with palpation.2.Anemia 3.Type 2 diabetes 4.Hypertension 5.Elevated cholesterol.On (b)(6) 2014 the patient presented for bdmc/pyelonphritis.Assessments: thoracic or lumbosacral neuritis or radiculitis, unspecifi ed; personal history of malignant neoplasm of testis; major depressive disorder, recurrent episode, moderate; insomnai, unspecified; impotence of organic orgin; diabetes mellitus without mention of complication, type ii or unspecified type, not stated as uncontrolled.On (b)(6) 2014 as per emergency room report the patient presented with dysuria-bladder problem.Impression: urinary tract infection; hyponatremia; hyperglycemia.The patient was admitted with severe orthostatic hypotension and resultant fall; possible sepsis due to recurrent urinary tract infection; acute kidney injury due to volume depletion and acute tubular necrosis; anemia of chronic disease; diabetes mellitus; candidiria.On (b)(6) 2014 as per final consultation report, assessment: hypovoemic hyponatremia; uti; bladder outlet obstruction; leukocytosis.On (b)(6) 2014 the patient underwent ct abd/pelvis w/o contrast.Impression: marked bladder distention with re-demonstration of air in the bladder wall.There is marked dilatation of the right upper collecting system with an air-fluid level in the right renal pelvis.Mild distention of left upper collecting system is stable.The patient presented with infectious disease consultation.Impression: recurrent multidrug resistant klebsiella urinary tract infection; anemia; type ii diabetes; hypertension; elevated cholesterol.On (b)(6) 2014 the patient discharged.Discharge diagnoses: complicated urinary tract infection, imaging with duplicated renal system; recurrent urinary tract infections; chronic orientation to self-catheterization; diabetes; chronic back pain; hyponatremia, improved; hyperglycemia with diabetes.On (b)(6) 2014 the patient presented for hospital follow up, pain medication refills.Assessments: thoracic or lumbosacral neuritis or radiculitis, unspecified; diabetes mellitus without mention of complication, type ii or unspecified type, not stated as uncontrolled; unspecified infection of kidney; anxiety state, unspecified; insomnia, unspecified; personal history of malignant neoplasm of testis.On (b)(6) 2014 the patient presented with weakness, low blood pressure and hypotension.Assessment: sepsis and lactic acidosis secondary to urinary source; anemia; renal insufficieny; type ii diabetes; hypertension; elevated cholesterol; urinal retention.On (b)(6) 2014 the patient presented with urinary tract infection and retention.On (b)(6) 2014 the patient presented for diabetes check.Assessments: diabetes mellitus without mention of complication, type ii or unspecified type not stated as uncontrolled; thoracic or lumbosacral neuritis.Musculoskeletal: abnormal gait, pain in lumbar region of back.On (b)(6) 2014 the patient underwent ct abd/pelvis w/o contrast.Impression: improved right-sided hydronephrosis; moderate to severe diffuse colonic fecal retention.According to emergency room report the patient presented with acute abdominal pain, urinary tract infection, dehydration, right sided pleuritic chest pain.On (b)(6) 2014 the patient presented with constipation and abdominal pain.Assessment: urinary tract infection; anemia; diabetes; urinary retention; hypertension; elevated cholesterol.On (b)(6) 2014 the patient discharged from hospital.Discharge diagnoses: severe obstipation; abdominal pain secondary to fecal rete ntion; recurrent urinary tract infection; chronic right-sided hydronephrosis; history of nephrolithiasis; acute cystitis; chronic back pain; diabetes hypercholesterolemia.On (b)(6) 2014 the patient underwent chest pa+lat.The patient underwent radionuclide pulmonary ventilation/perfusion scan for shortness of breath.Conclusion: very low probability for pulmonary embolus.(b)(6) 2014: the patient presented complaining of dizziness and nausea.Impression: 1.Hypotension 2.Status post fall rule out secondary to hypotension 3.History of recurrent urinary tract infections.5.Diabetes 6.Hypercholesterolemia (b)(6) 2014: the patient presented with right sided pain because of a fall.Impression: chronic changes of the right kidney with a duplicated system and chronic ureteropelvic junction obstruction without causing any symptoms with resulting chronic atrophy of that lower pole moiety.On (b)(6) 2014 the patient presented for diabetes check.Assessments: diabetes with other specified manifestations, type ii or unspecified type, uncontrolled; nausea with vomiting; syncope and collapse; other specified hypotension.On (b)(6) 2014 the patient presented for diabetic check.Assessments: thoracic or lumbosacral neuritis or radiculitis, unspecified; post laminectomy syndrome, lumbar region; chronic pain syndrome; diabetes with other specified manifestations.Type ii or unspecified type, not stated as uncontrolled.On (b)(6) 2014 the patient presented for diabetic check.Assessments: diabetes mellitus without mention of complication, type ii or unspecified type, not stated as uncontrolled; post traumatic stress disorder; (b)(6) 2014: the patient presented complaining of left side rib pain and right knee pain.The patient presented for x-rays of chest pa and lat due to chest pain.Conclusion: no acute disease.The patient underwent x-rays of right knee due to pain.Conclusion: no trauma or osteoarthritis.The patient also presented for x-rays of ribs unilateral due to pain post trauma.Conclusion: no fracture.The patient also underwent ct scan of the abdomen /pelvis without contrast due to pain.Conclusion: no significant interval change.Stable left renal cortical cyst.Stable probable right duplex collecting system with inferior pole moiety pelvicalycealdilation and cortical atrophy.No new renal pathology.Unremarkable bowel.No obstruction or uniform thickening of the urinary bladder wall.On (b)(6) 2014 the patient presented for diabetic check.Assessments: thoracic or lumbosacral neuritis or radiculitis; insomnia, unspecified; diabetes mellitus without mention of complication, type ii or unspecified type, not stated as uncontrolled; post traumatic stress disorder; chronic pain syndrome; unspecified infection of kidney; need for prophylactic vaccination and inoculation, influenza; need for prophylactic vaccination against streptococcus pneumonia.On (b)(6)-2002: the patient underwent mri of spine.Impression: c6-7 spondylosis.The patient underwent c6-7 anterior cervical discectomy, fusion and plating with allograft bone and microscopic dissection.As per op notes, the wound was copiously irrigated with antibiotic laden irrigation and a bone graft of a 9 mm size packed with autologous bone chips from the drilling and placed into the c6-7 space.A 25mm atlantis plate was placed over the c6-7 level and its position verified with fluoroscopy.Then 15 mm screws were placed, two into the c6 and two into the c7 bodies under fluoroscopic guidance.Patient states that numbness and tingling prior to or has now resolved (b)(6)-2002: the patient underwent x-ray of cervical spine.Impression: anterior plate and threaded screws overlying c6 and c7, mild straightening of the spine.(b)(6) 2007, (b)(6) 2007: the patient presented with diagnoses of spondylolisthesis, ddd and underwent l5-s1 interlaminar procedure on (b)(6) 2007, post op one day, the patient presented with low back pain, high blood pressure and poorly controlled diabetes assessment: hypertension, type ii diabetes.On (b)(6) 2007 the patient underwent vus duplex scan leg vein-unilat.Impression: no evidence of deep venous thrombosis in the right leg.On (b)(6) 2007 the patient presented with urinary retention, constipation, hypertension, and high blood sugar (poorly controlled dia betes mellitus).The patient reported that they had self-catheterized themselves after the surgery and were being followed by an urologist for this.Assessment: hypertension, constipation.Fleets enema.

Event Description

It was reported that on (b)(6)-2002: as per medical records, the patient underwent x-ray of cervical spine, x-ray of foot.(b)(6)-2004 the patient underwent frontal and lateral of the chest.Impression: there is no radiographic evidence of active cardiopulmonary disease.On (b)(6)2004 the patient underwent ct abdomen and pelvis with contrast.Impression: status post cholecystectomy; bilateral renal c ysts; distended urinary bladder.The patient underwent three views of right ribs.Impression: lower cervical fusion is, again, noted.There is calcific density adjacent to the greater tuberosity of the right humerus consistent with calcific tendonitis.On (b)(6)2005 the patient underwent single view chest.Impression: bibasilar interstitial changes in the lungs which may be acute or chronic.The patient underwent two views of abdomen.Impression: non obstructive intestinal gas pattern.On (b)(6)2006 the patient underwent ct abdomen and pelvis without contrast renal stone protocol.Conclusion: a 1.9cm soft tissue structure adjacent to the body of the pancreas, possibly representing a lymph node or a variation in pancreatic anatomy.This is unchanged over the last 2 years and can be considered benign; new moderate hydronephrosis on the right side.This appears to be secondary to a 6 mm stone with two smaller stones at the right upj.These stones were present previously, so it isnot clear why the patient now has developed hydronephrosis; deformity of the right renal cortex consistent with prior episodes of infarct, infection or reflux.This is unchanged; stable left renal cyst; massice distention of the urinary bladder.This is a new finding.; focal area of dilatation of the right ureter, of uncertain significance.On (b)(6) 2006 the patient presented with diagnosis images.Impression: duplicated right collecting system and ureter with dilation of the inferior moiety and inferior ureter.On (b)(6) 2007 the patient underwent single portable view of chest.Impression: unremarkable portable chest.On (b)(6) 2007 the patient underwent ct of head.Impression: normal ct head.On (b)(6) 2007 the patient underwent 2 views of the lumbar spine.Impression: no evidence of acute injury.On (b)(6) 2007 the patient underwent sonogram of the scrotum performed assessing gray scale appearance and color doppler flow.Impression: findings compatible with left epididymoorchitis; small right sided hydrocele, possible with some septations, suggesting complex nature.On (b)(6) 2008 the patient underwent spiral axial imaging was obtained through the abdomen and pelvis without contrast administration, using renal stone protocol and technique.Impression: continued distended urinary bladder which could be due to bladder outlet obstruction, neurogenic or atonic bladder; deformed mid and lower pole of the right kidney with a stable 3 mm perinephric calcification; disteniton of the right collecting system felt to be secondary to a 4mm calculus at the right upj in a similar location to the prior stone obstruction; 3 cm cyst stable in the left kidney.On (b)(6) 2008 the patient underwent 5mm axial images were obtained from the lung bases to the symphysis pubis without oral or iv contrast.Impression: 3mm stone adjacent to the right renal pelvis is felt to be extraluminal; irregular thickening of the urinary bladder wall representing either outlet obstruction or neurogenic/atonic bladder; stable left renal cyst.On (b)(6) 2008 the patient underwent myelogram due to low back pain.Impression: no definite nerve root sleeve cut off is identified.(b)(6) 2012: the patient underwent non contrast axial images which were obtained through the facial bones followed by sagittal and coronal reformats.Impression: diffuse infiltration of the subcutaneous fat of the right cheek suggestive of cellulitis; multiple dental caries.(b)(6) 2013: the patient underwent grayscale imaging with duplex doppler analysis.Impression: 6 x 6 x 3 mm hypoechoic focus in the left testicle.(b)(6) 2013: the patient underwent axial imaging without intravenous contrast was undertaken through the head.Coronal and sagittal r eformations were obtained.Impression: normal ct scan of the head.The patient underwent diagnosis for shortness of breath.Impression: normal chest.(b)(6) 2014: the patient underwent axial; helical images of the abdomen and pelvis were obtained following the administration of 75 ml of isovue 370 nonionic iv contrast.Impression: prior cholecystectomy; massive enlargement of the urinary bladder with an air-fluid level.There is extensive gas within the wall of the urinary bladder and both ureters.There is gas present within bilateral renal collecting systems.(b)(6) 2014 the patient underwent radionuclide renal scan performed after the intravenous administration of 2.1 mci tc-99m labeled dtpa and 10.3 mci tc 99m labeled mag3; posterior perfusion images and curves, as well as delayed function/excretion images and curves submitted.Patient was administered 50 mg of lasix intravenously 20 minutes after mag3 to assess for obstruction.Impression: slightly diminished perfusion in the left kidney with relatively symmetric contribution to gfr bilaterally.There is decreasing activity in the collecting systems over time, consistent with no significant obstructive change.Negative for significant response to lasix.On (b)(6) 2014 the patient underwent chest , single view, portable.Impression: no radiographic evidence of an acute cardiopulmonary disease process.On (b)(6) 2014 the patient underwent spiral ct imaging of the abdomen and pelvis was performed without iv or gi contrast.Conclusion: interval decrease distention and air-fluid levels upper pole collecting system right kidney.Negative for residual hydronephrosis right upper pole; interval decrease distention and resolution of air-fluid levels in the inferior collecting system right kidney although with residual asymmetric distention.This may relate to duplicated collecting system.Negative for nephrolithiasis or nephroureterolithiasis; interval decompression of the bladder although with residual extensive bladder wall thickening.Negative for bladder calculi.Bladder wall thickening may relate to distended, atonic bladder.Otherwise radiographic appearance is nonspecific; extensive fecal retention throughout the colon when distention of the anorectal region.This is most suggestive for severe obstipation.(b)(6) 2014: the patient underwent pulse doppler as well as doppler evaluation of the testes.Impression: increasing bilateral complex hydroceles; interval clearing of left testicular hypoechoic lesion, presumable representing resolved orchitis.(b)(6) 2014: the patient underwent helical ct of the abdomen and pelvis was performed from the lung bases to the public symphysis without iv or oral contrast.Additional 2d reconstructed images performed.Conclusion: abundant stool, correlate clinically regarding impaction; probable right duplex collecting system with stable pelvicalyceal dilation lower pole moiety right kidney with cortical atrophy, possible upj obstruction; stable left renal cortical cyst.Persistent urinary bladder wall thickening, correlate clinically regarding cystitis.(b)(6) 2014: the patient underwent axial images of the brain without iv contrast, sagittal and coronal 2d reconstructions.Conclusion: unremarkable ct brain without contrast.The patient underwent single view chest because of chest pain.Impression: clear lungs.(b)(6) 2014: the patient underwent helical ct of abdomen and pelvis was performed from the lung bases to the public symphysis without iv or oral contrast.Additional 2d reconstructed images performed.Iv contrast withheld due to iodine allergy.Conclusion: stable left renal cortical syst; stable probable right duplex collecting system with inferior pole moiety pelvicalyceal dilation and cortical atrophy; unremarkable bowel, no obstruction or inflammation; stable uniform thickening of the urinary bladder wall, correlate clinically regarding cystitis.(b)(6) 2014: the patient underwent three-view left ribs.Conclusion: no fracture.The patient underwent two-view right knee progress indication: pain.Conclusion: no trauma or osteoarthritis.The patient underwent frontal and lateral radiographs of the chest.Conclusion: no acute disease.

Manufacturer Narrative

Review of radiographic images found as follows: (b)(6) 2003 ct abdomen/pelvis no spinal implants are noted on this study.Accurate measure of the foramen and canal are not possible on this study.On (b)(6) 2004 chest film 2 views some hilar prominence bilaterally.Hear shadow normal.Under penetrated.Bony anatomy normal.Cervical acdf plate noted at c7/t1.On (b)(6) 2004 chest film 2 views of right lung field shows hilar prominence again.No clear effusions are seen.Rib details show no evidence of fracture.Ap view of upper abdomen shows vascular staples consistent with previous cholecystectomy.On (b)(6) 2005 chest film 1 view poor inspiratory film results in widened mediastinum and hilar vessel prominence.On (b)(6) 2006 ct abdomen and pelvis no new data is provided.Numerous studies of this type have been performed and previously reported.On (b)(6) 2006 urethrocystography shows dilated right ureter with possible blockage infra renal.No spinal pathology verified.On (b)(6) 2007 chest x-ray normal bone and cardiac shadows.Lower lung fields are underpenetrated, but do not appear to have infiltrates.On (b)(6) 2007 single pa chest x-ray supine portable film shows poor inspiration leading to vascular prominence.Ribs are not well maintained.Head ct occiput and c1 are seen only.Skull ct shows normal neural relationships.On (b)(6) 2007 lumbar films 2 views lumbar construct at l5/ s1 is again seen.4 screws with lateral connectors and two rods.Posterolateral fusion bone is seen.Interbody device is appreciated.Films are under penetrated.On (b)(6) 2007 us scrotum not contributory on (b)(6) 2008 ct abdomen/pelvis construct at l5/s1 is seen with interdiscal spacer.Study is not designed to provide spinal detail.Degree of fusion cannot be verified.On (b)(6) 2008 ct abdomen/pelvis construct at l5/s1 is seen with interdiscal spacer.Study is not designed to provide spinal detail.Degree of fusion cannot be verified.On (b)(6) 2008 lumbar myelogram needle is placed into dural sac behind l4/5 disc.Minor narrowing is seen at l4 although not stenotic.Root sleeves appear to fill out normally.Two lateral lumbar films again underpenetrated show the pedicle screws but detail is lost due to poor technique.Lumbar postmyelogram ct right l5 screw penetrates the vertebral body for three threads, coming near the right iliac artery.Heterotopic bone is seen along the insertion path for the spacer at l5.It does not appear to compress or distort the exiting l5 or transitioning s1 roots.Posterolateral bone does not appear solid.No stenosis centrally is appreciated.Fusion is solid through the capstone interbody spacer introduced on the left.On (b)(6) 2012 ct abdomen/pelvis no new spinal pathology.Implants remain at l5/s1 (b)(6) 2012 ct abdomen and pelvis scout view shows lumbo-sacral pedicle screw construct.Lumbosacral spine is seen with wide decompression at l5/s1.Pedicle screw position is obscured buy artifact from the implants.Coronal views are reconstructed however no further spinal pathology is verified.On (b)(6) 2012 head ct brain is midline throughout.Ao and junction and odontoid atlas junction appears normal.On (b)(6) 2013 head ct no new findings pa chest film shows hilar prominence.Bone anatomy, diaphragm and bony shadows are all normal.Cervical plate is still in place.On (b)(6) 2014 ct abdomen and pelvis lumbosacral spine is seen with wide decompression at l5/s1.Pedicle screw position is obscured buy artifact from the implants.Coronal views are reconstructed however no further spinal pathology is verified.On (b)(6) 2014 ct abdomen/pelvis scout view shows lumbo sacral pedicle screw construct.Lumbosacral spine is seen with wide decompression at l5/s1.Pedicle screw position is obscured buy artifact from the implants.Coronal views are reconstructed however no further spinal pathology is verified.On (b)(6) 2014 ct abdomen /pelvis scout view shows lumbo sacral pedicle screw construct.Lumbosacral spine is seen with wide decompression at l5/s1.Pedicle screw position is obscured buy artifact from the implants.Coronal views are reconstructed however no further spinal pathology is verified.On (b)(6) 2014 ct abdomen/pelvis construct at l5/s1 is again seen.No new spine pathology findings are evident.On (b)(6) 2014 chest x-ray single ap is slightly rotated.Hilar prominence is again seen.Lung fields are clear.Hear shadow is normal.Bony anatomy and diaphragm are normal.On (b)(6) 2014 ct abdomen/pelvis scout view shows lumbo sacral pedicle screw construct.Lumbosacral spine is seen with wide decompression at l5/s1.Pedicle screw position is obscured buy artifact from the implants.On (b)(6) 2014 ct abdomen/pelvis scout view shows lumbo sacral pedicle screw construct.Lumbosacral spine is seen with wide decompression at l5/s1.Pedicle screw position is obscured buy artifact from the implants.On (b)(6) 2014 chest pa and lateral films hilar prominence is again seen.Lung fields are clear.Hear shadow is normal.Bony anatomy and diaphragm are normal.Cervical plate remains (b)(6) 2014 ct abdomen/pelvis scout view shows lumbo sacral pedicle screw construct.Lumbosacral spine is seen with wide decompression at l5/s1.Pedicle screw position is obscured buy artifact from the implants.On (b)(6) 2014 chest film hilar prominence is again seen.Lung fields are clear.Heart shadow is normal.Bony anatomy and diaphragm are normal.Cervical plate remains (b)(6) 2014 chest series hilar prominence is again seen.Lung fields are clear.Hear shadow is normal.Bony anatomy and diaphragm are normal.Cervical plate remains rib details show no evidence of rib fracture.Three views of the right knee show no evidence of fracture.Patella is well positioned.Joint space is well maintained without signs of arthritis.

Event Description

On (b)(6) 2013 per billing records, the patient underwent echocardiography.On (b)(6)-2003 the patient was admitted in hospital with preoperative diagnosis of right renal mass hypotonic bladder.The patient underwent cystoscopy; right ureteral retrogrades (duplicated system), right ureteroscopy; right stent insertion; cystolithopaxy of bladder calculus using yag laser; transurethral resection of the prostate.The patient was presented in hospital with ct-scans.Impression: right renal lesion; diabetes mellitus; hypertension.On (b)(6) 2003 patient presented with preoperative diagnosis of duplicated right collecting system with right urteropelvic junction obstruction and calculus.Patient underwent dismembered pyeloplasty of lower portion of duplicated collecting system with removal calculous material.The patient arrived in recovery room in good condition.The patient discharged with diagnoses of duplicated collecting system with obstruction of lower pole collecting system and calculus mellitus; diabetes mellitus; hypertension; exogenous obesity; postoperative ileus.(b)(6)-2003: the patient presented with right side abdominal pain.Doctor's impression: 1.Right flank pain, 2.Possible right renal infection, postoperative.3.Non-insulin-dependent diabetes.On (b)(6) 2003 patient presented with wound infection.Clinical impression: 1.Right wound infection.2.Non-insulin-dependent diabetes.(b)(6) 2004 the patient was admitted to the operating room with the following pre-op diagnoses: 1.Right ureteral obstruction and duplicated collecting system.2.Hypotonic bladder with urinary retention.The patient had tur prostate and he also had cystoscopy, retrogrades of a double collecting system on his right including rigid and flexible ureteroscopy.The microscopic examination showed prostate, transurethral resection.Glandular and stromal hyperplasia with chronic inflammation and foreign body giant cell reaction.No evidence of malignancy.The patient also underwent four intraoperative retrograde right urethrograms which showed a duplicated right renal collecting system and ureter.The post-op diagnoses are 1.Hypotonic bladder with urinary retention 2.Duplicated right collecting system with ureters joining in the intramenal segment and with obstruction of the intramural lower ureteral segment.3.Mild obstruction of right ureteropelvic junction.(b)(6) 2004 the patient was discharged from the hospital.On (b)(6) 2004 patient admitted with chief complaint of right sided pain.Clinical diagnosis: 1.Contusion abdominal wall.2.Contusion chest.(b)(6) 2005 the patient presented with abdominal pain.The patient underwent conscious sedation to facilitate the attempt for closed reduction of the ventral hernia.(b)(6) 2005 the patient presented with complaints of wheezing.The patient also had throat closing sensation, feeling light headed, nauseated and had rash which was pruritic.Impression: allergic reaction to ultracet.On (b)(6) 2005 the patient presented with chronic pain in the right lower quadrant and hernia at an incision in the abdominal wall.X-ray evaluation of upright and flat abdominal series showed a partial bowel obstruction.The patient underwent single view chest.Impression: bibasilar interstitial changes in the lungs which may be acute or chronic.On (b)(6) 2006, reportedly, the patient presented in er with acute right flank pain.The patient underwent ct abd/pelvis w/o contrast.Conclusion: a 1.9 cm soft tissue structure adjacent to the body of the pancreas, possibly representing a lymph node or a variation in pancreatic anatomy; new moderate hydronephrosis on the right side; deformity of the right renal cortex consistent with prior episodes of infarct, infection or reflux; stable left renal cyst; massive distention of the urinary bladder on (b)(6) 2006 patient underwent urethrocystography retrograde.Impression: duplicated right collecting system and ureter with dilation of the inferior moiety and inferior ureter.Patient presented with preoperative diagnosis of right flank pain with hydronephrosis on ct and a right duplicated system.Patient underwent surgery.Post operative diagnosis was no obstruction seen.Patient arrived in recovery room in good condition.On (b)(6) 2007 the patient underwent ct of head.Impression: normal ct head.The patient was presented in hospital complaining of back.The patient was initiated on oxycontin and vicodin as needed as well flexeril.The patient underwent cardiovascular assessments, ent assessments.(b)(6) 2008 the patient presented for the evaluation of right sided flank pain.No clinically significant lab abnormalities.On (b)(6) 2008 the patient underwent ct lumbar spine w/contrast.Impression: post surgical changes are seen at the l5-s1 level.(b)(6) 2012: the patient presented with left ear pain and left facial numbness.He also reported left sided weakness and inability to feel areas of left side of face.(b)(6) 2013: the patient underwent grayscale imaging with duplex doppler analysis.Impression: 6 x 6 x 3 mm hypoechoic focus in the left testicle.Underlying neoplasm was also in the differential.The patient presented complaining of left testicle swelling and pain.The pain had been throbbing.(b)(6) 2013: the patient presented for office visit with left epididymal orchitis.Assessment: left epididymal orchitis with the possibility of an early abscess.Impression: suspect testicular abscess; rule out scrotal cellulitis; rule out orchitis; rule out epididymitis; uncontrolled diabetes melltus; neurogenic bladder.(b)(6) 2013 the patient was discharged from the hospital.(b)(6) 2013 the patient underwent neurological assessments, cardiovascular assessments, respiratory assessments, integumentary assessments, musculoskeletal assessments, gastrointestinal assessments, genitourinary assessments, pain assessments, fall risk assessments, safety/precautions assessments.On (b)(6) 2013 patient admitted with chief complaint of nausea, vomiting.Doctor's assessment was: 1.Pyelonephritis, 2.Dehydration, 3.Tachycardia with early systemic inflammatory response syndrome, 4.Right testicular mass, 5.Hypertension, 6.Diabetes type 2 7.Chronic pain.On (b)(6) 2013 patient underwent imaging and pulse doppler and color doppler evaluation of the testes due to pyelo, follow up epididymitis.Impression: increasing bilateral complex hydroceles.Patient presented with left flank pain.Doctor's impression: left flank pain is the most likely musculoskeletal in origin.(b)(6) 2013: the patient presented with flank pain, groin pain.The patient was admitted in hospital with admitting diagnosis of left scrotal abscess versus hematoma and secondary diagnosis of urinary tract infection; type ii diabetes; renal insufficiency of unclear chronicity; accessory right kidney; post traumatic stress disorder; mild protein-calorie malnutrition; hypertension.Asssessment: left scrotal swelling, abscess versus hematoma.Impression: left epididymoorchitis with infected hydrocele.The patient underwent scrotal ultrasound assessment.Conclusion: hyperemia of left testicle, epididymal thickening, and loculated hydrocele; there is a large amount of inhomogeneous material posterior to the testicle; small right hydrocele.(b)(6) 2013: the patient presented for office visit.Impression: epididymitis/orchitis/hydrocele; urinary tract infection; diabetes m ellitus; history of hypertension.(b)(6) 2013: the patient presented with preop diagnosis of left epididymo-orchitis and patient underwent left scrotal exploration, left orchiectomy.(b)(6) 2013: patient underwent a surgery to remove left testicle.On (b)(6) 2013 patient underwent ct head/brian without contrast.Impression: normal ct scan of the head.(b)(6) 2014 the patient underwent neurological assessment, eent assessments, visual acuity assessments, respiratory assessments, mus culoskeletal assessments, gastrointestinal assessments, genitourinary assessments, psychosocial assessments, pain assessments, mobility assessment, fall risk assessment, iv/central/peripheral line assessments.The patient presented with hematuria x 3 days, burning with urination.(b)(6) 2014 the patient underwent cardiovascular assessment, braden scale assessments (b)(6) 2014.The patient presented complaining of hematuria, right flank pain, pressure on the bladder and unable to urinate.Impression: acute onset hematuria, etiology of which is unclear, possibly related to a bladder wall hemorrhage itself.No obvious calculus seen; bilateral hydronephrosis, possible related to bladder outletobstruction from clots with associated severe hydronephrosis on the right as well as moderate hydronephrosis and possible pyelonephritis from urinary stasis; acute pain related to hydronephrosis and possible pyelonephritis form urinary stasis; rectal wall thickening , nflammatory versus vs underdistention of unclear significance; anemia related to acute blood loss from hematuria; diabetes mellitus type ii; hypertension; hyperlipidemia; chronic back pain; duplicated renal kidneys on the right; history of testicular carcinoma, status post resection.(b)(6) 2014 the patient was discharged from the hospital on (b)(6) 2014 the following problems were recorded: hypercholesterolemia, type ii diabetes mellitus, kidney infection, kidney stone, acute pyelonephritis, chronic back pain, numbness, hernia.On (b)(6) 2014 the patient underwent mobility assessment, fall risk assessment, safety/precautions assessment, peripheral line assessments, picc assessments.On (b)(6) 2014 the patient discharged with a diagnosis of early sepsis due to urinary tract infection; urinary tract infection with candiduria; severe orthostatic hypotension; acute kidney injury due to acute tubular necrosis and volume depletion; diabetes mellitus with renal complication; history of systemic hypertension; urinary retention secondary to neurogenic bladder.On (b)(6) 2014 patient presented with abdominal pain along with the constipation ongoing for last few days.Doctor's impression: 1.Abdominal pain, suspected secondary to fecal retention, 2.Recurrent urinary tract infection, 3.Right-sided hydronephrosis, 4.History of kidney stones in the past, 5.Chronic back pain, 6.Diabetes, 7.Hypercholesterolemia, 8.Hypertension.On (b)(6) 2014 urine analysis showed large leukocyte esterase, greater than 50 wbc.(b)(6) 2014 the patient presented with right shoulder/rib pain.On (b)(6) 2014 no significant interval change other than removal of picc line.On (b)(6) 2014 patient underwent helical ct of the abdomen and pelvis without iv or oral contrast.Conclusion: no fracture, no evidence for intra-abdominal trauma.Abundant stool, correlate clinically regarding impaction.No bowel inflammation.Probable right duplex collecting system with stable pelvicalyceal dilatation lower pole moiety right kidney with corticalatrophy, possible upj obstruction.Stable left renal cortical cyst.Persistant urinary bladder wall thickening, correlate clinically regararding cystitis.Patient presented with low b/p, dizziness, nausea and pain as patient tripped over dig and fell.(b)(6) 2002 the patient presented with the history of cervical pain, right arm pain and underwent mri of the cervical spine due to cervical pain.Impression: 1.Right c6-7 disc protrusion into the intervertebral foramen, which would impinge upon the exiting right c7 nerve root.There is some diffuse disc bulging at this level.2.Diffuse disc bulging at c3-4 with no discrete focal lateralizing disc protrusion.(b)(6) 2002 the patient presented with the history of diabetes and hypertension.The patient underwent renal ultrasound study due to renal stones which showed small appearing cyst in the mid portion of the right kidney measuring approximately 1.2 cm in size.It also demonstrated apparent duplex right renal collecting system without evidence of hydronephrosis.The patient also underwent x-rays of the abdomen.Impression: no evidence of renal calculi or other significant abnormality.(b)(6) 2002 the patient underwent nuclear medicine renogram with gfr due to renal stones and diabetes.Impression: 1.Small right kidney.In view of the duplicated upper collecting system, consider significant stenosis in a renal artery supplying the upper pole.It is to be noted that on a prior ultrasound study of (b)(6) 2002 the left kidney was smaller than the right, the right kidney measuring 12.6 cm in length and the left measuring 11.3 cm in length.2.A well-defined t-1/2 for the right kidney was not obtained.The t-1/2 for the left kidney is prolonged.3.Findings of renal parenchymal disease bilaterally as discussed above.4.The gfr of 100.97 cc per minute is normal.(b)(6) 2002 the patient underwent mri of the lumbar spine without contrast due to back pain.Impression: mild sized grade 1 anterior spondylolisthesis of l5 on s1, with bilateral neural foraminal narrowing, right side greater than left.(b)(6) 2003 per billing records, the patient underwent ct of the abdomen and pelvis.(b)(6) 2004 the patient underwent renal ultrasound due to post op right renal repair.Impression: 1.Apparent small right kidney with apparent separation of a lower polar moiety.The exact understanding of the current renal anatomy (post surgery) is unclear.There is fat extending into a cleft between the upper and mid kidney and the lower kidney which would be better clarified by ct.2.Small benign-appearing left renal cyst.3.No hydronephrosis.4.Significant post void residual bladder volume.(b)(6) 2004 the patient underwent intravenous pyelogram with tomograms to check scar tissue.Impression: 1.Mild to moderate hydronephrosis of the lower pole moiety collecting system along with ureterectasis to the approximate level of the right ureterovesical junction.No calculus is identified in this area.The differential diagnosis includes stricture and scar or edema from previous surgery.2.Distortion of the right side of the urinary bladder which is probably postoperative in etiology.The urinary bladder is also distended on this examination.The urinary bladder could not be emptied on the study as the patient did not have his catheter with him.(b)(6) 2004 the patient presented with the history of right upj obstruction, renal calculi and underwent renal ultrasound study.Impression: 1.No ultrasonographic evidence of hydronephrosis.2.Unusual morphology to the right kidney, with the upper and lower pole moieties separated by either interposing fat, or scar.The appearance remains unchanged when compared to the prior examination.3.1.6 cm right renal cyst.4.Postvoid residual in excess of 500 cc.(b)(6) 2005 the patient underwent ct of the abdomen and pelvis with contrast due to abdominal mass, swelling, possible recurrent incision hernia.Impression: 1.Large anterior abdominal subcutaneous fluid collection with no intra abdominal extension.2.Duplicated right renal collecting system with interval pyeloplasty of the right lower renal moiety since the previous examination.3.Marked distension of the urinary bladder.(b)(6) 2007 the patient underwent carotid duplex ultrasound study due to occasional dizziness.Impression: no evidence of critical stenosis involving the carotid arteries of the neck.(b)(6) 2011 the patient underwent mri of the lumbosacral spine due to low back pain.Impression: status post l5-s1 pedicle screw fixation, posterior decompression, and interbody fusion with orthopedic hardware within customary position.Mild left l5-51 lateral recess encroachment.Mild to moderate bilateral l5-51 and mild bilateral l4-5 neural foraminal stenosis.Moderate volume of perithecal and perineural granulation tissue identified within the l5-51 anterior epidural space and encasing the exit zones of the s1 nerve roots bilaterally.L5-51 grade 1 anterolisthesis.Multilevel degenerative disk disease, as detailed above.Severely distended, trabeculated urinary bladder likely neurogenic.Significant pelvocaliectasis of the right renal inferior polar moiety which may be related to obstruction or reflux.

Manufacturer Narrative

Additional information: image review: image review findings: (b)(6) 2011 lumbar mri sagittal t12 images show a well fused l5/s1 spondylolisthesis grade ii.Pedicle screws are in place at this level.Desiccation and posterior bulging can be seen at l4 as well.The bulge is subannular.No stenosis is seen.Disruption in posterior elements is seen on sagittal views.T1 views appear to suggest foraminal stenosis at l5 as the disc has collapsed and the vertebral endplates are nearly touching in some areas and fused in others.Axial views show a single spacer placed from the left side.It is eccentric to the left and there is some distortion of the thecal sac at the level of the l5 annulus.A 7-8 mm cyst appears behind the spacer and abuts the traversing s1 root.Full laminectomy has been performed at this level.

Event Description

Per medical records, it was reported that on on (b)(6) 2007 imaging showed isthmic spondylosis at l5-s1 with degenerative disc disease and severe foraminal stenosis at that level.(b)(6) 2007: the patient underwent spect myocardial perfusion study and myoview stress test due to chest discomfort and hypertension.Conclusion: normal study.On (b)(6) 2007 patient presented for evaluation of cardiovascular risk.Post evaluation it was found that left axillary discomfort is highly atypical and probably not a manifestation of myocardial ischemia.On (b)(6) 2008 patient complained of cough and congestion.(b)(6) 2008: patient presented for medical checkup and update on toes being numb not fasting.Patient presented with right anterior leg pain.Assessment: lumbar spondylosis; lumbar radiculopathy; lumbago; post laminectomy syndrome.On (b)(6) 2008 ap lateral radiographs today show a solid fusion at l5-s1.(b)(6) 2008: patient presented with low back pain, status post fusion.Patient underwent myelography lumbosacral exam.Impression: no definite nerve root sleeve cut off is defined.Patient also underwent ct scan of lumbar spine with contrast.Impression: post surgical changes are seen at the l5-s1 level; there is increase in soft tissue density identified in the anterior extradural space.This is eccentric being more pronounced on the right.The findings most likely to represent epidural fibrosis; mild disc bulging and ligamentum flavum hypertrophy is developing at the l4-5 level.(b)(6) 2002: the patient underwent x-ray of chest, 2 views due to acd.Impressions: normal examination.(b)(6) 2002: the patient underwent ap, lateral and swimmers views of the cervical spine.Impression: post-operative change without complicating features noted.(b)(6) 2002: patient underwent ap and lateral views of the cervical spine.Findings: an anterior plate and threaded screws overlying c6 and c7.There appears to be mild straightening of the spine.The vertebral bodies demonstrate normal height.The visualized disk spaces are preserved.Evaluation of the spine is slightly limited, secondary to increased overlying soft tissue, particularly in the lower cervical spine.There is no definite evidence of an acute process.The prevertebral soft tissues appear unremarkable.(b)(6) 2002: the patient presented with post-op numbness and pain down the posterolateral aspect of the buttocks and thigh, down the knee.Impression: status post c6-7 anterior cervical discectomy.Patient has new symptoms of pain and numbness involving the legs which is likely due to compression of the nerve roots, from l5-s1 stenosis.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3802653
• MDR Text Key: 5855000
• Report Number: 1030489-2014-02465
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2010
• Device Catalogue Number: 7510400
• Device Lot Number: M110701AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 05/09/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/29/2014; 11/25/2014; 12/16/2014; 01/12/2015; 02/18/2015; 03/30/2015; 05/22/2015; 06/19/2015; 06/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 99