|
MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
|
Back to Search Results |
|
| Catalog Number 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Ossification (1428); Chest Pain (1776); Cyst(s) (1800); Diarrhea (1811); Dyspnea (1816); Fever (1858); High Blood Pressure/ Hypertension (1908); Laceration(s) (1946); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Pneumonia (2011); Pneumothorax (2012); Scarring (2061); Swelling (2091); Tachycardia (2095); Weakness (2145); Burning Sensation (2146); Chills (2191); Hernia (2240); Discomfort (2330); Injury (2348); Numbness (2415); Respiratory Tract Infection (2420); Obstruction/Occlusion (2422); Nasal Obstruction (2466); Ambulation Difficulties (2544); Hematuria (2558); Abdominal Distention (2601)
|
|
Event Type
Injury
|
|
Event Description
|
|
It was reported that patient underwent a transforaminal lumbar interbody fusion, a posterolateral fusion, and a posterior fusion from l5-s1 where rhbmp-2/acs was implanted.The patient's post-operative period has been marked by low back pain that radiates into the lower extremities, nerve injury, and bone overgrowth.It is reported that the patient continues to suffer from lower back pain that radiates into his lower extremity and left leg due to nerve injury caused by bony overgrowth on his spine.
|
| |
|
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).
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2010: the patient presented with right inguinal pain.He underwent a computed tomography of the abdomen and pelvis.Opinion: negative examination.On (b)(6) 2010: the patient presented with right groin pain and underwent x-rays of the hip.Impression: negative exam.On (b)(6) 2011: the patient presented with bilateral lower extremity sciatica.The patient underwent a mri of the lumbar spine.Impression: minimal 2mm left parasagittal bulging disc at l5-s1; otherwise, normal mri of the lumbar spine.On (b)(6) 2012: the patient presented with pain in the low back, the entire left lower extremity, thoracic area and right thigh.The patient reports numbness and burning in these areas.The patient has undergone physical and massage therapy as well as unspecified injections.The patient reports unexplained weight loss.The patient reports weakness in the lumbar and thoracic spine and left leg.The patient also reports difficulty swallowing.Diagnosis: lumbar facet arthropathy, spinal enthesopathy; post laminectomy syndrome lumbar; lumbar degenerative disc disease; arachnoiditis; radiculopathy; lumbar spondylosis; lumbar myofascial sprain/strain.On (b)(6) 2012: the patient presented with pain in the lumbar spine bilaterally, both hips and both legs.The patient had the following pre-operative procedure: radiculopathy at l4-5 and l5-s1; post-laminectomy syndrome lumbar; arachnoiditis and lumbar degenerative disc disease.The patient underwent a caudal epidural steroid injection.No patient complications were noted.On (b)(6) 2012: the patient presented with the following preoperative diagnoses: post-laminectomy syndrome, lumbar; lumbar spondylosis with facet arthropathy l5-s1 left.The patient underwent a left lumbar medial branch blocks at s1.No patient complications were noted.On (b)(6) 2012: the patient presented with low back pain greater than bilateral lower extremity pain.The patient reports pain began as a result of a heavy load and a pulling injury.The patient recdently had a lumbar epidural steroid injection and reported minimal improvement in pain level.Diagnosis: post-laminectomy syndrome lumbar; arachnoiditis; lumbar facet arthropathy; lumbar degenerative disc disease; lumbar spondylosis; lumbar myofascial sprain/strain.On (b)(6) 2012: the patient presented with the following pre-operative diagnoses: lumbar post-laminectomy syndrome; lumbar facet arthropathy l4-5 left; lumbar degenerative disc disease.The patient underwent a left lumbar medial branch blocks at l4-5.On (b)(6) 2012: the patient presented with the following pre-operative diagnoses: radiculopathy at l4-5 and l5-s1; lumbar degenerative disc disease multiple levels; post-laminectomy syndrome lumbar; arachnoiditis.The patient underwent a left transforaminal epidurop lasty.On (b)(6) 2013: the patient presented with low back pain equal to bilateral lower extremity pain.The patient states the left leg pain is worse than right leg pain.The patient has undergone previous lumbar medial branch blocks.Racz.Diagnoses: postlaminectomy syndrome lumbar; arachnoiditis; lumbar degenerative disc disease; radiculopathy.On (b)(6) 2013: the patient presented to doctor's office for follow up.Diagnoses: post-laminectomy syndrome lumbar; arachnoiditis; lumbar degenerative disc disease; radiculopathy; tobacco use disorder.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2011: patient presented with isthmic spondylolisthesis with back and leg pain.Impression: grade 1 isthmic spondylolisthesis with bilateral leg radiculopathy, l5-s1 disc degeneration with disc bulge and foraminal stenosis.On (b)(6) 2011: patient underwent mri of lumbar spine.Impression: minimal about a 2 mm left parasagittal bulging disc at l5-s1.2.Otherwise, normal mri of the lumbar spine.On (b)(6) 2012 patient presented for an office visit for medication refill.
|
| |
|
Manufacturer Narrative
|
|
Depuy expedium pedicle screw system (rods/screws), concorde curve cage, graft expander/extender (implant (b)(6) 2012).
|
| |
|
Event Description
|
|
It was reported that the patient presented with preoperative diagnosis of l5-s1 isthmic spondylolisthesis with bilateral foraminal stenosis.The patient underwent: l5-s1 posterior segmental instrumentation using depuy expedium titanium screws with cobalt chrome 5.5 mm rods; l5-s1 posterior spinal fusion with 9 mg of rhbmp-2 on 10 ml of bone matrix at 1.5 mg per ml concentration combined with 5 ml of local morselized autograft; l5-s1 left-sided transforaminal lumbar interbody fusion; l5-s1 anterior intervetebral device consisting of a depuy concorde curve 11 millimeter height cage; l5-s1 anterior spinal fusion with a combination of 5 ml of local morselized autograft and 3 mg of rhbmp-2 at a 1.5 mg per ml conc entration on acs sponge; intraoperative spinal cord monitoring.As per op notes, the patient's entire lumbosacral spine was prepped with alcohol followed by duraprep.Sterile drapes were applied to the entire lumbosacral spine covered with ioban and straight midline incision from approximately l4 to the sacrum was made.A subperiosteal dissection was performed bilaterally from the l5 transverse process through the sacral ala.Appropriate size pedicle screw from the depuy expedium titanium pedicle screw systems with 5.5-millimeter cobalt chrome rods were placed.A combination of an amb bur and a half-inch osteotome were used to perform a left-sided laminotomy at l5, removing the entire l5 inferior facet.Using a penfield-2 and a penfield-1 to protect traversing and exiting nerve root, an annulotomy at l5-s1 was performed.Next, a discectomy was performed.An anterior spinal fusion was next performed with a combination of 5 ml of local morselized autograft that were placed anterior to the intervertebral disk space along with 1 ml of rhbmp-2 at a 1.5 mg per ml concentration on an acs sponge.This was then placed anterior with a bone tamp.Next, the concorde curve cage was placed into the l5-s1 intervertebral disk space and positioned appropriate with a tamp.A posterolateral spinal fusion was performed on the right side.The am8 bur was used to decorticate the l5-s1 facet joint as well as the transverse process of l5 and the sacral ala.5 ml of morselized local autograft was placed within the l5-s1 facets joint which was combined with 9 mg of rhbmp-2 and 10 ml of graft expander/extender matrix and were placed into the facet joint as well as over the l5 transverse process and sacral ala for posterior and posterolateral fusion.Two appropriately cut and bent 5.5-millimeter cobalt chrome rods were then placed into the pedicle screws on the right and left and secured with set plugs that were then torqued and counter-torqued.On (b)(6) 2012 the patient presented for radiology for spine lumbar 2 or 3 views.Impression: posterior fusion and anterior interbody fusions procedure at l5-s1; pars defects at ls; minimal s-shaped curvature lumbar spine.Patient underwent x-ray for lumbar spine.Impression: posterior fusion and anterior interbody fusions procedure at l5-s1; pars defects at l5; minimal s-shaped curvature lumbar spine.On (b)(6) 2012 patient presented with back pain radiating down to left buttock.Physician's note was patient with soft tissue mass in left neuroforamen at l5-s1 and per doctor patient needed mri.Patient underwent ct scan of the lumbar spine without contrast.Findings: alignment of lumbar spine is grossly normal.Disc spaces are well-maintained.Post-surgical change noted posteriorly at l5-s1.T12-l1, l1-l2, l2-l3, and l3-l4 are grossly normal.L4-l5 has a broad based disc bulge.Pedicular screw seen at l5.On the axial images, there is soft tissue mass seen in the left neural foramen at l5-s1, incompletely evaluated.Mrl recommended for further evaluation.On (b)(6) 2012 patient presented with hip and leg pain.Doctor's impression was hip and low back pain.On (b)(6) 2012 patient underwent mri for lumbar spine without contrast.Impression: postoperative changes at l5 and s1 as above.No disc protrusion or extrusion is seen.No acute finding.On (b)(6) 2012 patient presented to undergo physical therapy to relieve low back pain.Outcomes: reh: increase strength in back; reh: decrease pain; reh: increase muscle length.On (b)(6) 2012 patient underwent x-ray for thoracic spine.Impression: normal thoracic spine on (b)(6) 2012 patient underwent mri of lumbar spine on (b)(6) 2012 patient underwent ct scan of lumbar spine without contrast.Impression: previous discectomy and posterior fusion with spinal rods and pedicle screws at ls-sl.No acute finding; non obstructive left-sided renal calyceal calculus.On (b)(6) 2013 patient presented with low back discomfort and pain.Patient was given injection.On (b)(6) 2013 patient underwent ct scan for abdomen pelvis without contrast.Impression: left nephrolithiasis without hydronephrosis or ureterectasis.Note there were calcifications in the area of the pelvis which are probably vascular.On (b)(6) 2013 patient presented with pain.Doctor recommended medication.On (b)(6) 2013 patient presented with complaints of hurting in legs, back and neck.Patient underwent cerebellar testing which showed no evidence of ataxia with finger-nose-finger.Patient also underwent cardiovascular testing which showed no bruits, no meningismus, s1/s2 was present, no pedal edema.Doctor's impression were low back pain, neck pain, limb pain, paresthesias of the upper and lower extremities.Doctor recommended mri and nerve conduction studies.Patient also underwent mri of lumbar spine without contrast.Impression: non diagnostic study.Patient also underwent mri of cervical spine without contrast.Impression: minimal disc bulge at c4-c5.No central canal stenosis or neural foraminal narrowing at any level.Patient underwent neurology examination which demonstrated abnormal nerve conduction velocity studies of both upper extremities.Conclusions: mild right carpal tunnel syndrome; mild left carpal tunnel syndrome; probable entrapment of the right ulnar nerve across the elbow; probable entrapment of the left ulnar nerve across the elbow.On (b)(6) 2013 patient underwent mri of lumbar spine without contrast enhancement with saggital and coronal reconstruction and 3d reformation on independent workstations.Impressions: degenerative disc disease and post-op changes with orthopedic hardware l4-l5 and l5-s1.On (b)(6) 2013 patient presented with pain.Patient underwent neurology examination which demonstrated abnormal nerve conduction velocity studies of the lower extremities.Conclusions: nerve conduction velocity testing of the right sciatic nerve shows axonal abnormality due to peripheral nerve entrapment; nerve conduction velocity testing of the left sciatic nerve also shows axonal abnormality due to peripheral nerve entrapment; prolonged right h-reflex responses can be seen in s1 radiculopathy; the tibial and peroneal motor nerves bilaterally as well as the sural and superficial peroneal sensory nerves bilaterally are normal without evidence of polyneuropathy.On (b)(6) 2014 patient presented with abdomen pain, low back pain, buttock pain, tailbone pain, left leg pain, right leg pain, neck pain and mid-back pain.Patient underwent cervical epidural injection.On (b)(6) 2014 patient presented for cesi #1.Assessments: lumbar and sacral osteoarthritis; cervical disc degen; therapeutic drug monitor; failed back syndrome (lumbar); radicular pain; facet syndrome; acroiliac pain; cervical disc displacmnt; tobacco use disord-unsp.Patient underwent cervical inter-laminar epidural injection with fluoroscopy.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2009, per billing records, the patient was admitted to urgent care division (b)(6) 2010, per billing records, the patient was admitted to urgent care division.On (b)(6) 2011, the patient presented for urine culture hold and medicine refill.On (b)(6) 2011, per billing records, the patient was admitted to urgent care division.On (b)(6) 2012: patient presented to undergo physical therapy to relieve low back pain.Outcomes: reh: increase strength in back; reh: decrease pain; reh: increase muscle length.On (b)(6) 2012, the patient presented for physical therapy as the patient was experiencing back pain and radiation.On (b)(6) 2012, the patient was discharged from physical therapy.On (b)(6) 2013: the patient presented for laboratory /pathology test.As per plaintiff fact sheet: patient had underwent fusion surgery on lumbar sacral with anterior and posterior approach.Currently patient complains of bone overgrowth, extreme back pain, numbness from lower back to feet, tingling at the bottom of feet, lose control of left leg, swelling around the surgical site, incontinence, kidney stones, erectile dysfunction, difficulty walking, foot drop, depression, and bone spurs.On (b)(6) 2012: patient underwent l5-s1 surgery.
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2006 the patient underwent ct of abdomen and pelvis without contrast due to left flank pain, renal calculi.Conclusion: no hydronephrosis or obstructing renal calculi were demonstrated.There were two small non-obstructing left renal calculi; there was medullary nephrocalcinosis.Correlation with reversible causes was recommended.This can be caused by hypercalcemia, renal tubular acidosis and other etiologies; bilateral pars defects at l5 with grade 1 anterolisthesis; there was a tiny calcific density adjacent to the iliac vessels on the right.There were no hydronephrosis and hydroureter on the right.This may represent a vascular calcification.This could be further distinguished with intravenous contrast if clinically indicated.On (b)(6) 2006 the patient underwent ct of abdomen and pelvis performed without intravenous contrast due to history of kidney stones, left lower quadrant pain.Conclusion: no hydronephrosis or obstructing calculi.Unchanged appearance of two small non-obstructing calculi in the left side.Remainder of examination was unchanged as well.On (b)(6) 2006 the patient underwent ct of lumbar spine without contrast due to back pain.Conclusion: bilateral spondylolysis at l5-s1.Does not appear to be acute.There was some sclerosis of the pars defect.No acute abnormality identified.On (b)(6) 2006 the patient underwent x-rays of right foot due to foot injury.Impression: no fracture.On (b)(6) 2006 the patient underwent ct of the lumbar spine/non contrast study.Conclusion: spondylolysis l5-s1 without frank spondylolisthesis; small disc protrusion of the left side, l5-s1, without nerve compression apparent and likely stable from a prior lumbar ct of (b)(6) 2006.It was noted that the patient has had small renal calculi demonstrated in the past on abdomen and pelvic ct.The doctor did not see any evidence of obstructive uropathy on this study.On (b)(6) 2006 the patient underwent ct of right upper extremity, right wrist due to carpal strain.Conclusion: no acute fractures seen; small, benign-appearing probable cyst within the dorsal lunate bone; if an acute ligamentous or tendinous injury was clinically suspected, the doctor recommended an mri of the wrist for further evaluation.On (b)(6) 2006 the patient underwent x-rays of right toes due to toe injury.Conclusion: there was a complete dislocation of the pip joint of the little toe, possibly an open injury.No associated fracture was seen.Single view of the toes did not show a fracture, dislocation, or bone destruction.This was a post-reduction study done probably after subluxation.On (b)(6) 2012 the patient underwent ct of the lumbar spine without contrast due to back pain.Impression: soft tissue mass, left l5 neural foramina, approximately 18x18 mm in size.On (b)(6) 2012 the patient underwent mri of lumbar spine without contrast due to pain.Conclusion: previous discectomy and posterior fusion with spinal rods and pedicle screws at l5-s1.No acute finding; non-obstructive left sided renal calyceal calculas; no disc protrusion or extrusion was seen.On (b)(6) 2013 the patient underwent ct of abdomen pelvis without contrast due to flank pain on the left.Impression: left nephrolithiasis without hydronephrosis or ureterectasis.On (b)(6) 2013 the patient underwent x-rays of chest portable due to chest pain.Impression: no acute chest findings.On (b)(6) 2013 the patient underwent x-rays of chest portable.Impression: tiny right apical pneumothorax.No focal consolidation or effusion.The patient also underwent x-rays of /hand 3 views rt due to trauma.Impression: no fracture or dislocation of the right hand.The patient also underwent x-rays of chest 2 views due to trauma.Impression: very small right apical pneumothorax, about 5% or less.The patient underwent ct of cervical spine without contrast due to history of assault, patient complained of right upper chest pain and dyspnea.Impression: unremarkable ct examination of the cervical spine.No acute fracture or listhesis.The patient underwent ct of head without contrast.Impression: normal ct of the brain without contrast.The patient underwent ct of chest, abdomen and pelvis with contrast.Impression: no acute injury detected; incidental left renal calculus.On (b)(6) 2013 the patient underwent ct of abdomen and pelvis without contrast.Conclusion: left 10 mm upj stone causing mild obstruction; moderate stool burden.The patient underwent ct of abdomen and pelvis wo contrast due to left flank pain and hematuria.Impression: 8mm calculus the left renal pelvis with no dilatation collecting structures.2mm non-obstructing calculus in the lower pole.On (b)(6) 2013 the patient underwent mri of lumbar spine wwo contrast due to pain.Impression: normal post-operative appearance at l5-s1.No other findings.On (b)(6) 2013 the patient underwent ct of lumbar spine wwo contrast due to back pain with radiculopathy.Impression: post operative changes from a previous discectomy and fusion with pedicle screws and spinal rods at l5-s1.Mild left-sided l5 neuroforaminal narrowing.No recurrent disc protrusion or extrusion was seen.Limited at l5-s1 due to hardware.Otherwise unremarkable appearing ct scan of the lumbar spine with and without contrast.On (b)(6) 2013 the patient underwent ultrasound of scrotum due to right testicle pain and evaluation for epididymitis.Impression: small bilateral hydroceles.No evidence of testicular torsion.Small complex right epididymal cyst.On (b)(6) 2014 the patient underwent ct of cervical spine without contrast due to neck pain.Impression: normal appearing ct scan of the cervical spine without contrast.On (b)(6) 2014 the patient underwent x-rays of chest portable due to cough.Impression: no acute findings.On (b)(6) 2015 the patient underwent x-rays of chest/portable due to chest pain.Impression: no acute findings.The patient also underwent ct of cervical spine without contrast due to history of mva.Impression: no acute cervical spine fracture or mal-alignment.The patient also underwent ct of chest, abdomen and pelvis with contrast due to mva.Impression: moderate motion artifact limits evaluation of the abdominal viscera, however there are no acute post-traumatic findings, within the limitations of the study; sub-acute right lateral ninth rib fracture; 4 mm non-calcified nodule within the left lower lobe.Non-contrast chest ct can be performed in 12 months time to assess stability.On (b)(6) 2015 the patient underwent x-rays of chest 2 views due to pain.Impression: bibasilar plate like atelectasis or scar.No definite acute finding.On (b)(6) 2015 the patient underwent x-rays of chest 2 views due to cough fever/chills.Impression: no acute findings.(b)(6) 2009: patient underwent ct of abdomen and pelvis due to indications of left lower quadrant and flank pain.Conclusion: no adenopathy, mass or ascetic fluid.There is a 3 mm stone in the mid left kidney which is not causing hydronephrosis.(b)(6) 2010: patient underwent ct of abdomen and pelvis due to indications of right flank pain.Conclusion: 5 mm lower pole calix calcification left kidney.No hydronephrosis.The appendix is unremarkable.(b)(6) 2010: patient underwent ct of abdomen and pelvis with and without contrast due to indications of right lower quadrant pain, nausea and vomiting.Impression: non-obstructive 7 mm left adrenal stone, unchanged.No hydronephrosis or hydroureter.No appendicitis, free air, free fluid or adenopathy.Overall no significant change.(b)(6) 2010: patient underwent scrotal ultrasound due to history of right inguinal and scrotal pain.Opinion: small bilateral hydroceles.Patient also underwent ct abdomen and pelvis due to abdomen pain.Opinion: negative examination.(b)(6) 2002 the patient presented with the diagnosis of lumbar strain.The patient was having difficulty with sleep at night and pain with palpation over bilateral para spinals at l3-5.The patient underwent physical therapy.(b)(6) 2003 the patient presented with the diagnosis of low back pain.(b)(6) 2003 the patient presented with the diagnosis of back pain with bilateral paresthesias.The patient also had l4 & l5 lower back pain, numbness in his leg area and sharp pain in his lower back.The patient underwent x-rays of the lumbar spine.Findings: l5 spondylolysis which has sclerotic margins suggesting this is chronic; no spondylolisthesis.The patient underwent mri of the lumbar spine without contrast.Impression: bilateral l5 spondylolysis which appears chronic; no spondylolisthesis or obvious cause for patient's leg pain.(b)(6) 2003 the patient presented with the complaint of left flank pain with radiation into his groin.He was unable to urinate.Diagnoses: ureteral stone; uti.The patient underwent ct of abdomen and pelvis without contrast due to left flank pain.Conclusion: small left lower pole intrarenal calculus.Approximate 5 mm x 3 mm distal left ureteral calculus, just above the left ureteral vesical junction, producing mild left hydronephrosis and left hydroureter.(b)(6) 2006 the patient presented with the complaint of left flank pain and pain in left lower quadrant.Diagnoses: kidney calculus; abdominal pain; elevated blood sugar.(b)(6) 2006 the patient complained of left lower back pain with radiation into his left groin.The pain was constant and severe.He also had blood in urine.Diagnosis: abdominal pain.(b)(6) 2006 the patient was admitted to the er with the complaint of tooth pain, left lower molar.Diagnosis: tooth abscess.(b)(6) 2006 the patient was status post mva and was admitted to the er with the complaints of developing back pain.The pain was described as shooting down left leg.Impressions: mva; back pain.(b)(6) 2006 the patient dropped approx.50 lb steel on right foot and complained of swelling and tenderness along the lateral side of foot.Impression: contusion, foot.(b)(6) 2006 the patient was admitted to the er with the complaint of pain to back and left flank with radiation down into left leg.Diagnosis: back pain.(b)(6) 2006 the patient presented with the diagnosis of carpal sprained strain.(b)(6) 2006 the patient presented with the diagnosis of tattoo infection.The patient had a tattoo in his left lower leg and it got red, one part started to drain.He also had fever.Diagnosis: cellulitis, leg.(b)(6) 2006 the patient was admitted to the er with the complaint of pain in right foot after striking it on door.Obvious deformity noted to right little toe in the extremities.Diagnosis: toe dislocation.On (b)(6) 2006 the patient underwent x-rays of right toes due to toe injury.Conclusion: there was a complete dislocation of the pip joint of the little toe, possibly an open injury.No associated fracture was seen.Single view of the toes did not show a fracture, dislocation, or bone destruction.This was a post-reduction study done probably after subluxation.(b)(6) 2007 the patient was admitted to the er with the complaint of pain in right upper molar.Diagnosis: tooth ache.(b)(6) 2012 the patient presented to the er and complained of chronic low back pain and discomfort.The pain was described as sharp, shooting and radiating.(b)(6) 2013 the patient complained of left flank pain with radiation into his groin x 3 days.Impression: kidney stones.(b)(6) 2013 the patient complained of left sided chest pain, left arm numbness and pain with inspiration.Ekg showed sinus tachycardia and no evidence of acute ischemia or injury pattern.Impression: non cardiac chest pain; pleurisy.The patient also complained of nausea.(b)(6) 2013 the patient stated that he was in altercation and had pain in right rib cage.He also had blurred vision in left eye and laceration of posterior base of left ear.Impression: traumatic pneumothorax.(b)(6) 2013 the patient was discharged from the hospital with the diagnosis of pneumothorax (b)(6) 2013 the patient complained of left flank pain with left sided abdominal pain.The pain was worsening and burning with urination with blood.Impression: microscopic hematuria.(b)(6) 2013 the patient complained of kidney stone and left flank pain/abdomen pain radiating down to his groin.The patient underwent ct of abdomen and pelvis without contrast.Conclusion: left 10 mm upj stone causing mild obstruction; moderate stool burden.The patient with the pre op diagnosis of left ureteral calculus.The patient underwent cystoscopy with insertion of left ureteral stent size 6-french x 28 cm and left retrograde ureteropyelogram.No complications were reported.Findings: stone pushed up into kidney.(b)(6) 2013 the patient with the pre op diagnosis of left renal calculus 1 cm.The patient underwent left renal extracorporeal shock wave lithotripsy (eswl) procedure and possible intravenous pyelogram.No complications were reported.Findings: stone fragmented/disappeared.(b)(6) 2013 the patient presented to the ed for worsening pain from hernia.He complained of right testicle and groin pain.Impression: epididymitis.(b)(6) 2014 the patient presented with neck pain.He also complained of some pain down his right arm and lower mid line in his neck.(b)(6) 2014 the patient presented with left hip pain.The pain was described as radiating and sharp.Impression: sciatica of left side.(b)(6) 2014 the patient was admitted to the ed and complained of right sided rib pain.The patient had had tenderness to palpation in the right rib cage with no masses palpable.Patient's wbc is 13, which is consistent with pneumonia.Impression: pneumonia.(b)(6) 2015 the patient was status post motor vehicle collision and complained of abdominal pain.The patient was diaphoretic with elevated hr and bp.(b)(6) 2015 the patient presented to the ed reporting left lower anterior/posterior rib pain that began after moving/coughing 1-2 days ago.He was feeling as if he had a broken rib and has had a dry cough.Associated symptoms include chest pain.Ribs are ttp and patient's wbc is 10.7, flu was negative.Impression: pneumonia.(b)(6) 2015 the patient presented with the complaints of cough with green mucus x 3 days, nasal congestion, fever/chills and he was feeling very sick.Impression: upper respiratory infection.
|
| |
|
Manufacturer Narrative
|
|
Image review: (b)(6) 2006 ct abdomen pelvis bilateral pars defects l5 (b)(6) 2006 ct abdomen pelvis bilateral pars defects l5 (b)(6) 2006 ct l spine pt noted to be s/p mvc.Coronal and saggital reformats provided.Bilateral pars defects l5, preserved bony foraminal anatomy (b)(6) 2006 foot x ray no comment, no fracture by report (b)(6) 2006 ct l spine same findings (b)(6) 2006 ct wrist no comment (b)(6) 2006 x ray toe ¿ dislocation r small toe (b)(6) 2006 x ray post toe reduction (b)(6) 2009 abdominal/pelvic ct this study images the abdominal contents.The spine is noted to be uninstrumented.Alignment and bone anatomy appears normal.No stenosis, hnp, tumor or fracture is noted, posterior soft tissue elements are presurgical and appear to be in good overall condition.On (b)(6) 2010 ct abdomen and pelvis this study images the abdominal contents.There is no clear difference in the spinal anatomy demonst rated from the study of (b)(6) 2009.The spine is noted to be uninstrumented.Alignment and bone anatomy appears normal.No stenosis, hnp, tumor or fracture is noted.Posterior soft tissue elements are presurgical and appear to be in good overall condition.On (b)(6) 2010 ct abdomen and pelvis this study images the abdominal and pelvic contents.There is no clear difference in the spinal anatomy demonstrated from the study of (b)(6) 2009.The spine is noted to be uninstrumented.Alignment and bone anatomy appears normal.No stenosis, hnp, tumor or fracture is noted.Posterior soft tissue elements are presurgical and appear to be in good overall condition.Pelvic bony anatomy is also within normal limits.On (b)(6) 2010 ct abdomen and pelvis this study images the abdominal and pelvic contents.There is no clear difference in the spinal anatomy demonstrated from the study of (b)(6) 2009.The spine is noted to be uninstrumented.Alignment and bone anatomy appears normal.No stenosis, hnp, tumor or fracture is noted.Posterior soft tissue elements are presurgical and appear to be in good overall condition.Pelvic bony anatomy is also within normal limits.Testicle ultrasound no spinal anatomy imaged right hip series ap and lateral views show normal alignment without signs of arthritis or deformity.No fractures are seen.Cortical density appears excellent.On (b)(6) 2011 lumbar mri t1 and t2 sagittal and axial views are reviewed.Some early desiccation is seen in the l5 disc without any disc height decrease.Axial views show no stenosis, hnp, fractures etc.The spine again appears presurgical without pathology or signs of intervention.Isthmic defect is suspected at l5 but there is minimal listhesis.On (b)(6) 2012 ct l spine post op l5-s1 tlif.Hardware position appears appropriate.Report questions a soft tissue mass in l foramen (b)(6) 2012 mri l spine patent canal and foramen (b)(6) 2012 x ray t spine no acute finding (b)(6) 2012 ct l spine no overt change in hardware, foraminal appearance, fusion not present (b)(6) 2013 ct abdomen for flank pain.Has l kidney stone (b)(6) 2013 cxr no comment (b)(6) 2013 ct c spine s/p assault no bony injury (b)(6) 2013 ct head (b)(6) 2013 ct body no report provided.Coronal reformats only hardware appears unchanged (b)(6) 2013 x ray hand no comment (b)(6) 2013 x ray chest no comment (b)(6) 2013 ct abdomen no change from (b)(6) 2013 mr l spine +/- contrast hardware artifact limits evaluation at l5-s1, but overall appears grossly normal post op (b)(6) 2013 ct abdomen performed for hematuria shows kidney stones (b)(6) 2013 ct l spine bony fusion no complete in interspace, but probably is out lateral.Some new bony formation posterior to interbody graft, probably affecting l neural foramen.Series 10 image 32-33 (b)(6) 2013 scrotal ultrasound no comment (b)(6) 2014 ct cervical spine neck pain, no acute abnormality (b)(6) 2014 cxr no comment (b)(6) 2015 cxr no findings (b)(6) 2015 c spine ct s/p mva no acute findings (b)(6) 2015 ct chest abdomen pelvis difficult to assess hardware details.No other acute findings (b)(6) 2015 cxr atelectasis (b)(6) 2015 cxr unchanged.Narrative impression: pt with long standing diagnosis of l5 pars fractures sp stabilization in 2012.Medical history complicated by kidney stones as well as multiple trauma presentations.Overall hardware placement appears appropriate.One post operative ct may show a small amount of heterotopic bone formation which could impact the neural foramen/root.Root cause: surgical technique, patient related factors.
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2012: the patient presented with pain in the low back, the entire left lower extremity, thoracic area and right thigh.The patient reports numbness and burning in these areas.The patient has undergone physical and massage therapy as well as unspecified injections.The patient reports unexplained weight loss.The patient reports weakness in the lumbar and thoracic spine and left leg.Lumbar spine pain, left hip pain and morning stiffness lasting less than 1 hour.The patient also reports difficulty swallowing.Diagnosis: lumbar facet arthropathy, spinal enthesopathy; post laminectomy syndrome lumbar; lumbar degenerative disc disease; arachnoiditis; radiculopathy; lumbar spondylosis; lumbar myofascial sprain/strain.On (b)(6) 2012: the patient presented with low back pain greater than bilateral lower extremity pain.The patient reports pain began as a result of a heavy load and a pulling injury.The patient recently had a lumbar epidural steroid injection and reported minimal improvement in pain level.Lumbar spine: alignment- decreased lordosis and forward flexed.Inspection-scars present, no mass or masses and no skin lesions.Ten derness to palpation- bilateral paravertebralarea overlying the facet joints, left si joint, right si joint and bilateral posterior iliac crests in the distribution of the superior cluneal nerves.Range of motion is painful with lumbar flexion, lumbar extension, left lateral flexion and right lateral flexion.Patrick¿s test is positive bilaterally for sacroilitis.Lumbar spine nerve root provocation testing was negative.Diagnosis: post-laminectomy syndrome lumbar; arachnoiditis; lumbar facet arthropathy; lumbar degenerative disc disease; lumbar spondylosis; lumbar myofascial sprain/strain.On (b)(6) 2012: the patient presented with the following pre-operative diagnoses: lumbar post-laminectomy syndrome; lumbar facet arthropathy l4-5 left; lumbar degenerative disc disease.The patient underwent a left lumbar medial branch blocks at l4-5.No complications reported.On (b)(6) 2013: the patient presented with low back pain equal to bilateral lower extremity pain.The patient states the left leg pain is worse than right leg pain.The patient has undergone previous lumbar medial branch blocks.Racz.Pain is noted in the lower region of the lumbar spine.Diagnoses: postlaminectomy syndrome lumbar; arachnoiditis; lumbar degenerative disc disease; radiculopathy.On (b)(6) 2011, patient underwent lumbar spine radiography.Impressions: unchanged bilateral l5 pars defects with grade 1 anterolisthesis of l5, which increases slightly with flexion.On (b)(6) 2012 the patient underwent musculoskeletal diagnosis.Impressions: impaired joint mobility, motor function, muscle performa nce, and range of motion associated with bony or soft tissue surgery.On (b)(6) 2012, patient underwent lumbar spine radiographs.Impression: interval posterior spinal fusion procedure at l5-s1.At least one of the screws at the s1 level extends anteriorly to the sacrum; persistent grade 1 anterolisthesis of l5 on s1; bilateral pars defect at l5.On (b)(6) 2010: patient presented with low back pain.On (b)(6) 2011: patient underwent ct scan which shows a left renal stone, but no ureteral stones.Patient presented with inguinal pain and testicle pain.On (b)(6) 2011: patient presented with groin pain with leg numbness.Patient underwent mri of lumbar which shows a minute abnormality at the level of l5-s1.On (b)(6) 2011: patient presented with acute uri nos, acute sinusitis, uri, otitis media and uri w/o mcc.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2011: per billing records.Patient presented for an er visit.On (b)(6) 2011: per billing records, patient presented for an x-ray of pelvis.On (b)(6) 2011: per billing records, patient underwent a ct scan of abdomen and pelvis.On (b)(6) 2011: per billing record, patient presented with an x-ray of the knee.On (b)(6) 2011: per billing records, patient presented with the er visit.On (b)(6) 2011: per billing records, patient presented with an office visit.On (b)(6) 2011: per billing record, patient presented with an electrocardiogram interpretation and report.On (b)(6) 2012: per billing record, patient underwent following examination : an extensive spine spinal.On (b)(6) 2009 the patient underwent ct abdomen pelvis with contrast.Impression: tiny non-obst, ructivexx left renal calculus.Diver ticulosisxx, no evidence of diverticulitis.Normal appendix.On (b)(6) 2009, the patient underwent ct of abdomen pelvis with contrast.Impression: distention of the colon but no obstructing lesion or process is appreciated.On (b)(6) 2009, the patient presented with 1 week history of llq pain, abdominal pain the pain was associated with abdominal distention and diarrhea.He reports some bleeding per rectum.Obstructive series today with a lot of gaseous distention of the large and small bowel, but no free air.Diagnosis: colonic disorder, diverticulitis.Impression: 1.Diffuse colonic and small bowel gaseous distention.Etiology uncertain.Inflammatory bowel disease possible, infectious colitis possible.Diverticulitis seems unlikely.X-ray pattern not typical of a volvulus.No hernia on exam.The patient underwent x-ray abdomen acute series.Impression: improved inspiration.Mild residual bibasilar opacities, likely atelectasis.Improved bowel dilatation.A few remaining non-dilated small bowel loops within the mid abdomen and right upper quadrant, likely resolving ileus.On (b)(6) 2009, the patient presented with abdominal pain, diarrhea, and emesis.He was noted to have a distended colon.Diagnosis: colonic disorder, diverticulitis, dehydration.On (b)(6) 2010, the patient underwent us of scrotum and testicles.Impression: a 9 mm hypoechoic lesion within the right epididymal head which is nonspecific.Consider complex epididymal head cyst or other lesion.Urologic consultation is recommended for further evaluation.Slightly increased blood now to the right epididymis may be indicative of epididymitis.Slightly heterogeneous echogenicity of the right testicle without definite underlying mass.On (b)(6) 2010, the patient presented for an office visit and states that he has had four months history of groin pain, bilateral testicular pain, and lower abdominal pain.He states he has had a considerable weight gain over the course of the last four months and he has had particularly abdominal distention.On (b)(6) 2010, the patient presented with complaints of abdominal pain and groin.The x-ray studies showed that his colon was greatly distended and they also had made a call of epididymitis on an ultrasound.On (b)(6) 2010, the patient underwent ct head w/o contrast.Impression: normal non-contrast ct scan of the brain.On (b)(6) 2010, the patient presented with abdominal distention.He apparently also had a seizure.He continues to complain of bilateral groin pain.The patient underwent gastric biopsy which suggested thickened stomach.The pain is worse on the left.It is in the groin radiating up into the flank.Ct scan showed he had nothing more than small epididymal cyst.On (b)(6) 2010, the patient underwent x-ray of lumbar spine w/o contrast.Impression: spondylosis without spondylolisthesis, l5-s1.The patient underwent ct of head, cervical spine w/o contrast.Impression: normal head.Normal cervical spine.On (b)(6) 2010, the patient underwent x-ray of thoracic spine.Impression: there is no fracture seen.On (b)(6) 2010, the patient underwent ct head w/o contrast.Impression: no acute intracranial process.On (b)(6) 2010, the patient underwent x-ray of right hand.Impression: negative.On (b)(6) 2011: the patient presented with bilateral lower extremity sciatica, low back pain and groin pain.The patient underwent a mri of the lumbar spine.Impression: minimal 2mm left parasagittal bulging disc at l5-s1; otherwise, normal mri of the lumbar spine.On (b)(6) 2011, the patient presented with rectal bleeding.Musculoskeletal ros: right leg pain.Assessment: brbpr (bright red blood per rectum), abdominal pain right up quad, right inguinal pain.On (b)(6) 2011, the patient presented with lower back pain radiating into both buttocks.Assessment: lumbago.On (b)(6) 2011, the patient presented with bilateral groin pain and testicular.The mri scan showed that he has a very minute disc bulging of the l5-s1 disc on one side.On (b)(6) 2011, the patient presented with lower back pain radiating to the left calf and left thigh.Lumbar spine has tenderness.Lumbar spine has tenderness.Assessment: lumbago.On (b)(6) 2011, the patient was diagnosed for dentalgia.On (b)(6) 2011, the patient presented with middle back pain radiating to the right ingroin area.Assessment: backache nos.On (b)(6) 2011 the patient presented with lower back pain radiating to the left thigh.Assessment: lumbago, insomnia.On (b)(6) 2011, the patient underwent mri of lumbar spine which showed disc bulging disc at l3-4, l4-5 and l5-s1 and an annular tear at l5-s1 on the left.On (b)(6) 2011 ,the patient presented with lower back pain.Lumbar spine has tenderness.Sacroiliac joint bilateral tender.Assessment: lumbago, insomnia.On (b)(6) 2011, the patient for evaluation back pain and leg pain.He states he has had pain and has started having increased problems with weakness and numbness in his bilateral lower extremities, which is worse on the left side versus the right reports that the pain starts in his buttock area in each side and goes the side of his leg to his knee.He complains of numbness in the bottoms of his feet.Ap and lateral views of the lumbar spine were obtained, which shows minimal evidence of degenerative disk disease.He does have a l5 spondylolisthesis, which appears chronic.Impression: l5 bilateral pars interarticularis defects.On (b)(6) 2011, the patient presented with lower back pain radiating to the left thigh.Lumbar spine has tenderness.Assessment: lumbago.On (b)(6) 2011, the patient complains of low back pain, right lower leg pain and left lower leg pain.He complains of right arm pain and left arm pain radiating into the buttocks and lower extremities bilaterally towards the ankles and feet.The patient was diagnosed for: nerve root compression, lumbar, lumbar disc displacement/herniation, lumbago, mononeuritis of lower limb, unspecified.The patient underwent: lumbar epidural steroid injection.Complications none.On (b)(6) 2011, the patient presented with lower back pain and bowel incontinence.Pain is radiating to the left thigh and left buttock.Left pelvis has sacroiliac tenderness.Assessment: lumbago, sacroiliac joint disease.On (b)(6) 2011, the patient presented with lower back pain radiating to the left calf and left thigh.Physical examination: lumbar spine has tenderness.Left hip has tenderness.Assessment: sacroiliac joint pain.On (b)(6) 2011, the patient presented with back pain, low back pain, bilateral leg pain and imaging results.Musculoskeletal ros: joint pain.Physical examination: lumbar spine has tenderness.Left: pelvis has sacroiliac tenderness.Assessment: lumbago, insomnia.Grade 1 l5-s1 spondylolisthesis with mild instability seen on x-rays.Unchanged bilateral ls pars defects with grade 1 anterolisthesis of l5, which increases slightly with flexion.On (b)(6) 2011, the patient presented with back pain.The patient has left and right pelvis pain.Assessment: lumbago, insomnia, hypertension nos.On (b)(6) 2011, the patient presented with cold symptoms.Assessment: acute uri nos.On (b)(6) 2011, the patient presented with back pain.Assessment: spondylolisthesis of lumbosacral region.On (b)(6) 2011, the patient presented with back pain and upper respiratory infection.Assessment: lumbago, acute uri nos.On (b)(6) 2012, the patient presented with congestion and leg and back pain.Assessment: spondylolisthesis of lumbar region, benign hypertension.On (b)(6) 2012, the patient presented with hypertension and back pain.Assessment: hypertension, lumbago.On (b)(6) 2012, the patient presented for back surgery f/u post spinal fusion surgery on l5-s1.The patient states he needs l3 to l5 surgery due to disc bulging disc.Assessment: back pain.On (b)(6) 2012, patient presented with back pain radiating down to left buttock.Physician's note was patient with soft tissue mass in left neuroforamen at l5-s1 and per doctor patient needed mri.Patient underwent ct scan of the lumbar spine without contrast.Findings: alignment of lumbar spine is grossly normal.Disc spaces are well-maintained.Post-surgical change noted posteriorly at l5-s1.T12-l1, l1-l2, l2-l3, and l3-l4 are grossly normal.L4-l5 has a broad based disc bulge.Pedicular screw seen at l5.On the axial images, there is soft tissue mass seen in the left neural foramen at l5-s1, incompletely evaluated.Mrl recommended for further evaluation.Conclusion: soft tissue mass, left l5 neural foramina, approximately 18 x 18 mm in size.On (b)(6) 2012, the patient presented with back pain.On (b)(6) 2012, the patient presented with back pain.Assessment: back pain w/o radiation, trigger point to bilateral joint area.On (b)(6) 2012, the patient presented with back pain.Assessment: back pain w/o radiation, acute pain due to trauma.On (b)(6) 2012, the patient presented with multiple issues.The patient feels like he can't catch his breath when he lies down.Assessment: anxiety state unspecified, sciatica.On (b)(6) 2012, as per medical records, assessment: back pain w/o radiation, sciatica.On (b)(6) 2012, the patient presented with pain.Assessment: elevated bp w/o hypertension, sciatica.
|
| |
|
Search Alerts/Recalls
|
|
|
