|
MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
|
Back to Search Results |
|
| Catalog Number 7510200 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Cyst(s) (1800); Diarrhea (1811); Fatigue (1849); Headache (1880); Incontinence (1928); Muscle Spasm(s) (1966); Nausea (1970); Neuropathy (1983); Pain (1994); Swelling (2091); Urinary Retention (2119); Urinary Tract Infection (2120); Vomiting (2144); Weakness (2145); Dizziness (2194); Stenosis (2263); Injury (2348); Depression (2361); Numbness (2415); Respiratory Tract Infection (2420); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Claudication (2550)
|
|
Event Type
Injury
|
|
Event Description
|
|
It was reported that the patient underwent a spinal fusion surgery at l4 to s1 using rhbmp-2/acs.Patient's post-operative period has been marked by increasingly severe pain and weakness in her legs.It was reported that the patient underwent a revision surgery to decompress the exiting nerve roots at the implant site.Patient continues to experience severe and unrelenting pain that radiates into her lower extremities.Due to swelling and pain, patient is unable to sit or stand for long periods.She also developed bladder incontinence.
|
| |
|
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)(6).(b)(4).
|
| |
|
Event Description
|
|
It was reported that on, (b)(6) 2002, the patient presented for medicine refill.(b)(6) 2005, the patient underwent echd exam of abdomen.(b)(6) 2012 patient presented for follow-up for chronic back pain.(b)(6) 2012, patient presented for follow-up for chronic back pain at the lumbosacral joint with motion.(b)(6) 2012: the patient presented with history of back pain and lower extremity pain.Pain is typically across the lower back and travels into the bilaterally lower extremity down the posterior aspect of leg.She has numbness /tingling in the same distribution of pain.Pain is worse with ambulation and affects the activities of daily living.On physical examination it was found that patient is tender across the left paralumbar, right paralumbar muscles.Radiographic evaluation show lumbar degenerative disc disease at l4-s1.(b)(6) 2012 patient presented for follow-up and reported back pain, gluteal pain, right flank and thigh pain radiating into right foot.On (b)(6) 2012 patient presented for physical therapy.(b)(6) 2012 :.X-ray of lumbar spine are reviewed which show that the l4 through s1 segment seem to have been consolidated nicely over the posterolateral gutters and the interbody space.There is no evidence of instrumentation loosening or migration or adjacent level pathology.On physical examination patient has tenderness over the si joints and lumbosacral junction.Assessment: status post l5 through s1 decompression and fusion.2) right lower extremity radiculopathy.(b)(6) 2013: review of system reveals patient is positive for incontinence ,joint stiffness and depression.On physical examination patient has numbness on the lateral aspect of the right foot.Patient is tender to palpation in the right lumbosacral and gluteal region consistent with si joint.Opinion: 1) right gluteal pain consistent with sacroiliac dysfunction postoperatively.2) right s1 radiculopathy with diminished reflex and numbness in s1 distribution.(b)(6) 2013: patient presented for office visit and complains of right lower leg weak and loss of control bowels.(b)(6) 2013: patient presented for office visit with diagnosis of lumbosacral spondylosis without myelopathy.On (b)(6) 2013 patient presented for follow-up and reported bilateral leg pain.On (b)(6) 2013 patient presented for follow-up for back pain.(b)(6) 2013, the patient presented for pre-op clearance.On (b)(6) 2013 , the patient presented with preop diagnosis of spinal stenosis.(b)(6) 2013, the patient underwent physical therapy.On (b)(6) 2013 patient presented for follow-up for constant smell of car exhaust.On (b)(6) 2013 patient underwent spinal cord stimulator trial using a trial lead.On (b)(6) 2013 patient presented for follow-up for loss of sense of smell.(b)(6) 2013, the patient underwent spinal cord stimulator trial removal.On (b)(6) 2013 patient presented for follow-up before implantation of spinal cord stimulator.On (b)(6) 2014 patient presented for office visit and reported low back pain with numbness.On (b)(6) 2014 patient presented for office visit and reported paresthesia to hands.On (b)(6) 2014 patient was diagnosed with following pre-operative diagnosis : spinal cord stimulator battery malfunction and underwent removal of spinal chord stimulator battery, placement of advanced prime battery, revision of battery pocket with elevation of flap.As per progress note, the old battery was replaced with new one.No complications were reported.(b)(6) 2014: the patient also underwent, routine venipuncture , cmp, urinalysis , cbc , prothrombin, ecg on (b)(6) 2014 patient presented for office visit and reported back pain.On (b)(6) 2014 patient presented for office visit and reported abnormal smelling sensation of car exhaust with headache and dizziness.On (b)(6) 2014 patient presented for office visit and reported diffused joints aches with swelling.On (b)(6) 2014 patient presented for follow-up and reported increased back pain.(b)(6) 2014: patient went for an office visit due to chronic pain.19 aug 2014:patient presented with following impression: psychological factors affecting chronic pain, major depression.(b)(6) 2014; (b)(6) 2015 , per billing records the patient presented for aquatic physical therapy.On (b)(6) 2013 (b)(6) 2014, (b)(6) 2015 patient presented for office visit as per billing records on (b)(6) 2015 patient presented for office visit and reported acute upper respiratory infection with ear stuffiness, headache, nasal discharge, sinus, nausea and fatigue.On (b)(6) 2015 patient presented for office visit and reported headache, numbness of legs and chronic low back pain.On (b)(6) 2015 patient presented for office visit for low back pain, foot pain and bilateral leg pain.On (b)(6) 2015 patient presented for office visit and reported incontinence of urine, dribbling and urgency.On (b)(6) 2014, (b)(6) 2015 patient presented for annual exam post hysterectomy.On (b)(6) 2015 patient presented for office visit for headache.On (b)(6) 2015 patient presented for office visit for skin check.On (b)(6) 2014, (b)(6) 2015 patient presented for office visit for thoracic pain, lower leg pain, numbness, headache and bilateral leg pain.On (b)(6) 2015 patient underwent colonoscopy with biopsy.No complications were reported.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
(b)(6) 2007 patient presented with headache, vomiting and diarrhea.(b)(6) 2007 patient presented with vaginal irritation.(b)(6) 2007 patient presented with cervicitis, and dissociative identity disorder.On (b)(6) 2008 patient presented with back pain.Patient underwent x-ray lumbar spine.Impression: slight positional scoliosis, mild degenerative changes.On (b)(6) 2009, patient presented with headache.On (b)(6) 2009, (b)(6) 2008 patient presented with back pain.On (b)(6) 2009 patient presented for office visit.On (b)(6) 2009 patient presented with lumbago and pain in joint involving pelvic region and thigh.On (b)(6) 2009 patient underwent x-ray lumbar spine.Impression: slight positional scoliosis, mild degenerative changes and no evidence of acute fracture or subluxation.Patient also underwent x-ray left hip.Impression: mild degenerative changes and no evidence of acute fracture or subluxation.On (b)(6) 2009 patient presented with urinary tract problem.On (b)(6) 2009 the patient presented with disorder, panic, w/o agoraphobia.On (b)(6) 2009 patient presented with cough.On (b)(6) 2009 patient presented with back left hip and "lle" pain.On (b)(6) 2010 patient presented with urinary retention.On (b)(6) 2010 patient presented with pain in joint involving pelvic region and thigh, backache and anxiety.On (b)(6) 2010 patient presented for anxiety with panic.On (b)(6) 2010 patient presented with bladder problems and anxiety.On (b)(6) 2011, patient presented with sinusitis with symptoms of nasal congestion, cheek pain, upper tooth pain, forehead pain, ear pain and ear pressure.On (b)(6) 2011 patient presented for diarrhea and bad allergies.On (b)(6) 2011 patient presented for a physical exam with minor symptoms of fatigue and poor sleep.On (b)(6) 2011 patient presented for nausea and emesis.On (b)(6) 2012 patient was diagnosed with sacroilitis underwent the procedure of sacroiliac joint injection (under fluoroscopic guidance).On (b)(6) 2012 patient was diagnosed with ddd/poss disc tear and underwent lumbar discogram.On (b)(6) 2012 patient underwent complete review of systems.Examination of musculoskeleton organ system revealed decreased sensation on the right in the l5 distribution.Radiographic examinations revealed chronic mechanical back pain, mild lumbar degenerative disc disease, l4-s1; mild facet joint arthropathy, l4-s1.On (b)(6) 2012 patient was diagnosed with mechanical chronic lower lumbar pain and underwent lumbar provocative discography.On (b)(6) 2012 patient presented with complaints of persistent pain at the lumbosacral junction.The recent discogram ct scan showed grade 45 annular tears at l4-5 and l5-s1.On (b)(6) 2012 patient was scheduled for surgical intervention on (b)(6) 2012.On (b)(6) 2012 patient presented for follow-up and reported lower back pain and balance issues resulting in falls.Patient also followed up for her sacral pain.Patient underwent physical examinations which revealed sacrum/somatic dysfunction.(b)(6) 2012 the patient underwent x-ray of chest ap and lateral view.Impression: no signs of an acute cardiothoracic abnormality.(b)(6) 2012: the patient underwent x-ray of lumbar spine single view.Impression: circumferential fusion changes with laminectomy l4-sl.Normal single view postoperative appearance.On (b)(6) 2012 patient presented for anxiety.On (b)(6) 2012 patient called for medication management on (b)(6) 2012 patient presented for office visit with cold symptoms including, sneezing, nasal congestion, sore throat and productive cough.On (b)(6) 2012 patient presented for physical therapy treatment with chief complaint of back pain.Patient stated that the problem is worsening, persistent.Location of pain is gluteal area, right flank and thighs.Pain radiated to the right foot.On (b)(6) 2012 patient revisited for physical therapy treatment.On (b)(6) 2013 patient was diagnosed with sacroilitis and underwent si joint injection and lumbar transforaminal epidural.On (b)(6) 2013 patient was given injection at right si joint.On (b)(6) 2013 patient called and stated that she was not able to stand on her leg.She had fallen twice in the last 12 hours and stated that her foot was numb.She was also having bowel issues.On (b)(6) 2013 patient called and reported that her back pain, numbness and weakness had not improved.On (b)(6) 2013 patient was called and given her status post epi and ct.Patient stated that her right leg weakness and pain was not any better.She also complained of having pain on front of right leg, upper thigh and groin and having difficulty with urination.She stated that she was using a walker to ambulate around house.On (b)(6) 2013 patient presented for follow-up for lower back pain.The mri of the lumber spine was reviewed, which showed evidence of previous lumbar decompression and instrumented fusion at l4 through s1.There were no abnormalities of the instrumentation.There was some scar tissue around the area where the interbody cages were placed on the right.On (b)(6) 2013 patient called and stated concern regarding intake of ultram and lexapro, which she expressed had possible risks of serotonin syndrome, though she had not any symptoms for the same.On (b)(6) 2013 patient underwent psychological evaluations which had the following findings: depression and anxiety.(b)(6) 2013: the patient presented for an office visit due to feeling of numbness in right foot and unable to walk because of she had a fall a day before this visit.Examination of musculoskeleton organ systems revealed right lower extremity pain and radiculopathy.Patient complained of pain in back, right leg, and hip, and described the pain as sharp.She also had numbness and stiffness.She had medical conditions of arthritis and depression.The review of systems revealed: incontinence urinary problem and joint stiffness and joint pain.On (b)(6) 2013 patient underwent spine lumbar discectomy- bilateral l5-s1 decompression.No patient complications were reported.On (b)(6) 2013 the patient underwent x-ray of lumbar spine single view.Impression: surgical probe in line with superior aspect of l5 vertebral body.Surgical probe at the level of the dorsal aspect l5-s1 disc level.Stable appearance to l4-s1 fusion hardware and discectomies.On (b)(6) 2013 findings: these show surgical instruments dorsal to the t11 and t12 spinous processes.Posterior retractor is in place.There has been t12 laminectomy with placement of dorsal spinal cord stimulator into the canal at this site extending cephalad with the tip in the dorsal aspect of the canal at the t10 upper level.(b)(6) 2015 the patient underwent ct of lumbar spine with contrast due to thoracic or lumbosacral neuritis or radiculitis, unspecified.Impression: 1.Transitional anatomy, as described above.In correlation with the thoracic myelogram, there are 11 paired ribs with no demonstrable ribs on what would correspond to the t12 segment.Numbering of the lumbar vertebral segments has been altered to reflect a nonrib-bearing t12 segment with 4 lumbar vertebral bodies.2.With the above in mind, lumbar fusion is again noted involving the l3, l4, and s1 segments.Mild osteophytic spurring along the posterior aspect of the interbody spacer at the l3-4 level has slightly increased but there does not appear to be significant canal or foramina} stenosis.3.Previously described asymmetric disc bulge or protrusion on the right at l4-s1 has resolved and the associated nerve root sleeves at this level fill symmetrically.The patient underwent ct of thoracic spine with contrast.Impression: 1.11 paired ribs.2.Dorsal epidural stimulator extending from the t8-t9level to the lower margin of t10.3.Mild multilevel degenerative changes.4.Otherwise, unremarkable evaluation.The patient underwent myelogram.Impression: 1.Uncomplicated fluoroscopic guided myelogram.2.Additional post myelogram findings and ct findings will be dictated separately.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on: on (b)(6) 2011 patient underwent left sacroiliac joint injection.No complications were reported.On (b)(6) 2011 patient presented for follow-up for lower back, tailbone and leg pain.On (b)(6) 2011 patient presented for follow-up for lower back pain shooting down buttocks, thigh and leg.On (b)(6) 2011 patient presented for follow-up for lower back pain.On (b)(6) 2011: the patient presented with chief complaint of low back pain.It was in her lower back into the left side of her buttocks and left leg.Assessment: lumbar facet syndrome.Sacroiliitis.On (b)(6) 2011 patient presented for follow-up for lower back and leg pain.On (b)(6) 2011 patient presented for follow-up for lower back, buttocks and leg pain.On (b)(6) 2011 patient presented for follow-up for lower back and leg pain.On (b)(6) 2011 patient presented for follow-up for lower back and leg pain.On (b)(6) 2012 patient presented for follow-up for lower back, mid back and leg pain.On (b)(6) 2012 patient presented for follow-up for lower back pain going down through the buttock and into the hamstring region.On (b)(6) 2012 patient presented for follow-up for lower back pain into the buttock.On (b)(6) 2012 patient presented for follow-up for lower back pain and sacral pain.On (b)(6) 2012 patient presented for follow-up for lower back pain.On (b)(6) 2012: the patient underwent mri of lumbar spine without contrast due to low back pain.Impression: minor bilateral foraminal narrowing was seen at l4/l5, with minor foraminal narrowing seen on the right side at l5/s1.Minor bilateral facet arthroapthy.On (b)(6) 2012 patient presented for follow-up for lower back, hip, groin, leg and foot pain.On (b)(6) 2012: the patient underwent mri of pelvis with and without contrast due to urinary incontinence.Impression: there were two small cysts arising in the right ovary.No abnormality of the urinary bladder was seen.On (b)(6) 2012 patient presented for follow-up for lower back, leg and feet pain.On (b)(6) 2012: the patient underwent ct of lumbar spine with contrast due to degenerative disk disease.Impression: patient was status post multilevel discogram procedures (l2-l3 to l5-s1).Multilevel annular tears were identified which were most prominent at the l4-l5 (grade 5) and l5-s1 (grade 4) levels.The patient also underwent lumbar provocative discography for assessing degree of annular tear and concordant back pain.On (b)(6) 2012 patient presented for follow-up for lower back pain and tenderness over the lumbosacral junction.On (b)(6) 2012 patient presented for follow-up and reported lower back pain and balance issues resulting in falls.On (b)(6) 2012: the patient presented with history of back pain.Assessment: degenerative disk disease; spondylolisthesis; depression; hypotension.On (b)(6) 2012: the patient was examined due to history of back and lower extremity leg pain with no significant changes noted and was scheduled for surgery.Later, the patient presented with pre-op diagnosis of annular tear, spondylolisthesis, and degenerative disk disease.For which the patient underwent l3-s1 laminectomy for decompression, interbody cage and fusion l4-s1, instrumented fusion l4-s1, fluoro, bma, grafting.Per op notes, a complete discectomy was subsequently performed for interbody fusion from a trans-foraminal approach at l4-l5.Four cc's of local bone graft was packed at the interbody fusion levels as grafting material.A bone marrow aspiration was performed from the right iliac crest and mixed with tricalcium phosphate structural grafts.The beta tricalcium phosphate structural grafts were packed as a bone graft extender with the local bone and a large bone graft volume was noted.X-rays confirmed excellent position of the interbody fusion cages.The patient tolerated the procedure well with no complications being reported.On (b)(6) 2012: the patient presented with diagnosis of lumbar spondylosis, spondylolisthesis and underwent physical therapy evaluation.On (b)(6) 2012: the patient got discharged with stable condition.On (b)(6) 2012 patient presented for follow-up and reported transient leg pain.On (b)(6) 2012 patient presented for follow-up.On (b)(6) 2012 patient presented for follow-up and reported leg pain.On (b)(6) 2012: the patient presented for an office visit due to feeling of numbness in right foot and unable to walk because of she had a fall a day before this visit.On (b)(6) 2012 patient presented for follow-up and reported lower back pain.On (b)(6) 2012 patient presented for follow-up for lower back pain.Patient underwent lumbar transforaminal epidural.On (b)(6) 2013 patient presented for follow-up for lower back pain and underwent si joint injection and lumbar transforaminal epidural.On (b)(6) 2013 the patient underwent a right si joint injection for sacroiliitis.No complications were reported.(on b)(6) 2013: the patient presented for an office visit due to weakness of right lower leg and loss of control bowels.On (b)(6) 2013 the patient underwent lumbar transforaminal epidural steroid injection for radiculopathy and postlaminectomy syndrome.No complications were reported.Patient also underwent lumbar myelogram with ct to follow.On (b)(6) 2013: the patient underwent ct of lumbar spine with contrast due to history of back pain, prior lumbosacral fusion.Impression: post surgical changes status post posterior rod and bilateral pedicle screw fixation from l4-s1.Asymmetric disc bulge versus broad-based right paracentral to intraforaminal disc protrusion at l5-s1 is suggested with mild impingement upon the right s1 nerve root sleeve.Patient also underwent x-ray of lumbar spine.Impression: uncomplicated fluoroscopic guided myelogram.On (b)(6) 2013 patient presented for follow-up for lower back pain and increased leg pain with weakness in foot.On (b)(6) 2013 the patient underwent lumbar transforaminal epidural steroid injection for radiculopathy and failed back syndrome.No complications were reported.On (b)(6) 2013 patient presented for follow-up for lower back pain and increasing pain in right gluteal area over sacroilleac joint.On (b)(6) 2013 patient presented for follow-up for lower back pain and shooting pain down the posterior aspect of left leg with numbness.On (b)(6) 2013: the patient underwent mri of lumbar spine due to history of lower back and right lower extremity pain.Impression: l4-5, l5-s1 postoperative changes.L3-4 minimal retrolisthesis.On (b)(6) 2013 patient presented for follow-up for lower back pain.On (b)(6) 2013 patient presented for follow-up and reported back pain with pain radiating to the thighs and calves.Patient reported being depressed and had spinal stenosis with neurogenic claudication.On (b)(6) 2013 patient presented for follow-up for lower back pain and underwent spinal cord stim trial.On (b)(6) 2013 patient presented for follow-up and reported back pain with pain radiating to the thighs and calves.Patient categorized pain as constant, chronic and severe.On (b)(6) 2013 patient presented for follow-up and reported unexplained nerve pain, spinal problems and headaches.On (b)(6) 2013 patient presented for follow-up and reported back pain.On (b)(6) 2013 patient presented for follow-up and reported back pain and bilateral leg pain.On (b)(6) 2013 patient underwent mri study of lumbar spine.Impression: l5-s1, l4-5: postoperative changes.Little change compared to the previous study performed (b)(6) 2013.On (b)(6) 2013: the patient underwent x-ray of lumbar spine due to history of lower back pain.Impression: no evidence of instability with flexion and extension.On (b)(6) 2013 patient presented for follow-up and reported back pain.On (b)(6) 2013 patient presented for follow-up and reported back pain and bilateral leg pain.On (b)(6) 2013: the patient underwent x-ray of chest.Impression: no acute findings.On (b)(6) 2013 patient presented for follow-up and reported increased back pain at night and reduced leg pain.Patient also underwent bilateral l5-s1 foraminotomies and lateral recess decompressions.No complications were reported.On (b)(6) 2013: the patient underwent ct maxillofacial without contrast due to frontal headaches, abnormal smell sensation.Impression: normal.On (b)(6) 2013 patient underwent mri study of thoracic spine.Impression the thoracic spine was within normal limits.Cerebeller tonsillar ectopia (b)(6) 2013: the patient presented for an office visit.Assessment: disturbance of perception of taste and smell.On (b)(6) 2013 patient underwent spinal cord stimulator trial.No complications were reported.On (b)(6) 2013 patient presented for follow-up and reported increased back pain.On (b)(6) 2013 patient presented for follow-up and reported back pain and bilateral leg pain.Patient categorized pain as constant, chronic and severe.Patient also underwent x-ray.Impression: no active disease or interval change.On (b)(6) 2013: the patient underwent urinalysis and x-ray of chest.Pa and lateral.Impression: no active disease or interval change.On (b)(6) 2013 patient underwent placement of spinal cord stimulator electrode, placement of spinal chord stimulator generator, t12-l1, t11-t12 laminotomies.No complications were reported.Postoperative visit with doctor, where, the patient was anxious but stated her pain was controlled.On (b)(6) 2013 patient presented for follow-up and reported increased back pain.On (b)(6) 2014 patient presented for follow-up and reported back pain and concern about the charging of her stimulator battery.On (b)(6) 2014: the patient underwent x-ray of chest single frontal view.Impression: no significant abnormality.On (b)(6) 2014 patient underwent removal of spinal chord stimulator battery, placement of advanced prime battery, revision of battery pocket with elevation of flap.No complications were reported.As per plaintiff factsheet: patient underwent rhbmp2 on lumbar spine with tlif approach.Currently patient complains of radiating pain in the leg;nerve injury; ongoing right leg pain; chronic severe pain; loss use of right leg.Patient underwent second surgery, implantation and revision of spinal cord stimulator and bowel issues.Patient is unable to work, alleges depression and anxiety.Patient experience difficulty in bending over, numbness in feet.On (b)(6) 2013: patient underwent bilateral l5-s1 foraminotomies and lateral recess decompression.On (b)(6) 2013: patient underwent insertion of spinal stimulator.On (b)(6) 2014: patient underwent change battery in spinal stimulator and revision of flap (b)(6) 2014-present: patient complains of back pain.On (b)(6) 2013: patient had revision of spinal surgery.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on: (b)(6) 2003 the patient presented for evaluation of left knee injury, which she received when she slipped and fell landing directly on her left knee sustaining blunt trauma to her right knee.X-rays were obtained, which revealed obvious fracture of the inferior pole of the patella; the edges also appeared rounded.Impression: possible acute or subacute inferior pole of the patella fracture with complete active extension of the quads.On (b)(6) 2003 the patient presented with follow-up of left knee non-displaced fracture at the inferior pole of the patella.X-rays were also obtained which revealed non-displaced fracture of patella and the fracture appeared to be unchanged in its position.On (b)(6) 2005 the patient presented with diagnosis of primary ruq abdominal pain.Radiology interpretation; ct abdomen / pelvis shows, no aaa, no appendicitis, no diverticulitis, no kidney stones.Small ovarian cyst.On (b)(6) 2008 the patient with left wrist injury, underwent ¿dx wrist comp min 3 view lt¿.Impression: negative left wrist.On (b)(6) 2009 the patient presented for x-ray of left hip.On (b)(6) 2010 the patient presented for left hip 2 vu examination.Impression: early degenerative changes about both hips.On (b)(6) 2010 the patient presented for mri/ arthro of left hip.Impression: no evidence of acetabular lubral tear.Impression: arthrog ram of left hip ¿ left hip injection for mr screening as detailed above.On (b)(6) 2010 patient presented for office visit and reported hip pain, left more severe than right.On (b)(6) 2010 patient underwent mri lumbar spine without contrast.Impression: minor bilateralforaminal narrowing is seen at l4-5 with minor narrowing seen on the right side at l5-s1.It is uncertain whether these union areas of foraminal stenosis causing the patient¿s symptoms.These are due to a small posterior disc protrution at l4-5 and l5-s1; minor bilateral facet arthropathy as seen from l3-4 and l5-s1.(b)(6) 2010, per the billing records the patient presented for office visit.On (b)(6) 2010 the patient underwent mri of the lumbar region.Impression: mild diffuse disc bulge at the l4-5 and l5-s1, which is not s ignificantly changed from previous study.On (b)(6) 2010, the patient presented for urinalysis, cbc, chemistry, bmp.Impression: acute urinary retention, additional chronic lower back pain.On (b)(6) 2010 the patient presented for follow up due to his lower back pain.On (b)(6) 2010 the patient presented for pt (physical therapy) (b)(6) 2010 the patient presented with pre-op diagnosis of low back and left hip pain.On (b)(6) 2010 the patient presented for ma mammogram screening.On (b)(6) 2010 the patient presented for us breast unilat or bilat.Impression: probable benign findings most consistent with an intrama mmary lymph node and a cluster of cysts.On (b)(6) 2010 the patient was presented for office visit.On (b)(6) 2010, patient presented with chief complain of low back pain.On (b)(6) 2010 patient presented for office visit and reported back pain and depression.On (b)(6) 2010 the patient underwent 1) right l3-4, l4-5 and l5-s1 multi facet steroid injection.Preoperative diagnosis: lumbar facet syndrome.On (b)(6) 2011 patient presented for office visit with complaint of back pain.Assessments: hip pain, sacrolitis, lumbar facet syndrome.On (b)(6) 2011 the patient was presented for office visit with lumbar facet syndrome.On (b)(6) 2011, patient underwent following procedure: left l3 medial branch block with lidocaine under fluoroscopic guidance; left l4 medial branch block with lidocaine under fluoroscopic guidance; left l5 medial branch block with lidocaine under fluoroscopic guidance; right l3 medial branch block with lidocaine under fluoroscopic guidance; right l4 medial branch block with lidocaine under fluoroscopic guidance; right l5 medial branch block with lidocaine under fluoroscopic guidance.For pre-op diagnosis of: lumbar facet syndrome.No complications were reported.On (b)(6) 2011, per the billing records the patient presented for office visit.On (b)(6) 2011, patient presented for follow-up for continued pain in her lower back into the left side of her buttocks and left leg.On (b)(6) 2011, the patient requested for medicine refill.On (b)(6) 2011 patient presented for follow-up for lower back and leg pain.On (b)(6) 2011 the patient presented for follow up office visit.The patient is s/p a left sl injection on (b)(6) 2011 the patient states the pain has worsened one day after the injection (b)(6) 2011 patient presented for follow-up for lower back and leg pain.Assessments: lumbar facet syndrome and sacrolitis.On (b)(6) 2012 patient presented for follow-up for lower back pain into the buttock.Assessments: lumbar facet syndrome and sacrolitis.On (b)(6) 2012 patient presented for follow-up for lower back, hip, groin, leg and foot pain.Impression: mri lis minor bilateral foraminal narrowing is seen at l4/l5, with minor foraminal narrowing seen on the right side at l5/s1.It is uncertain whether these minor areas of foraminal stenosis are causing the patient's symptoms.These areas of narrowing or due to a small posterior disc protrusion at l4/l5 and l5/s1; minor bilateral facet arthropathy was seen from l3/l4-l5/s1.On (b)(6) 2013 patient underwent mri study of lumbar spine due to lumbar radiculitis.On (b)(6) 2011 the patient presented for physical therapy.On (b)(6) 2011, the patient was admitted for some procedure.On (b)(6) 2011 the patient presented with left sacroilitis.On (b)(6) 2011 the patient presented for ma mammogram screening.On (b)(6) 2012 the patient presented for follow up pt.Assessment: therapy diagnosis - patient presented with sign and symptoms of disc herniation and positional dysfunction with tight hip capsule.On (b)(6) 2013 the patient presented due to disturbances of sensation and underwent mri brain.Impression: mild inferior cerebellar tonsillar ectopia (b)(6) 2014 the patient experiencing headache, presented for ct head wo contrast headache once.Impression; normal non contrast head ct.The patient presented for eeg.On (b)(6) 2014 the patient presented for ma mammogram screening.Impression: negative bilateral digital mammogram.On (b)(6) 2015 the patient presented for follow up and underwent us bladder / abdomen.Impression: post void bladder volume residual of 7ml.On (b)(6) 2013 patient underwent mri study of thoracic spine due to mid back pain and bilateral shoulder pain.On (b)(6) 2014, the patient presented with low back pain and leg pain.The low back pain was primarily in the midline lumbar spine, over the bilateral lumbar paraspinal muscles and facet joint lines, over bilateral sacroiliac joints, and over the bilateral priformis muscles and referred pain down the leg most consistent with l5-s1 distribution.Assessment: postoperative chronic pain; lumbar postlaminectomy syndrome; myalgia/myositis; gait abnormality.On (b)(6) 2014, the patient underwent sacroiliac joint injection with ultrasound guidance due to sacroilitis.No patient complications were reported.Assessment: myofascial pain; sacroiliac pain.On (b)(6) 2014, the patient underwent psoas muscle injection with fluoroscopy due to psoas muscle spasm, genitofemoral neuralgia, illoinguinal neuralgia, back pain.Assessment: myalgia and myositis; neuritis and neuralgia.On (b)(6) 2015, the patient presented with low back pain and leg pain.The patient continued to have chronic low back pain, which radiated to the extremities.The pain was described as sharp, burning, dull and shooting.The patient also reported numbness, muscle weakness and difficulty walking.Assessment: postoperative chronic pain; chronic pain syndrome; back pain; sacroiliac pain; lumbar postlaminectomy syndrome; myalgia/myositis; gait abnormality.On (b)(6) 2015, the patient presented for follow up and underwent us bladder / abdomen.Impression : post void bladder volume residual of 7ml.On (b)(6) 2015, the patient underwent psoas muscle injection with fluoroscopy due to psoas muscle spasm, genitofemoral neuralgia, illoinguinal neuralgia, back pain.Assessment: myalgia and myositis; neuritis and neuralgia.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2002 patient presented with complaint of low back and right hip pain.Impression of radiographic studies: musculoskeletal low back pain that is chronic in nature.(b)(6) 2002 patient presented with complaint of musculoskeletal low back pain.She complained of having decreased range of motion of the back on forward flexion.Patient was diagnosed with low back pain, musculoskeletal etiology.(b)(6) 2004 patient presented with chief complaint of lower lumbar pain and was administered lumbar epidural steroid injection.(b)(6) 2006 patient presented with chief complaint of recurrent right sacroiliac (si) joint pain.(b)(6) 2009 patient presented with urinary tract problem.Study of patient's recent x-rays revealed degenerative changes and some degree of a positional scoliosis.Impression: recurrence of low back pain; mild ddd with musculoskeletal back pain.(b)(6) 2009 the patient presented with complaints of back pain and was administered lumbar epidural steroid injection at l3-4.(b)(6) 2010 the lumbar mri scan of (b)(6) 2010 was reviewed, which revealed a bulging vertebral disc l4-5 and l5/s1.Impression: lumbar ddd with back pain and sciatic leg pain.(b)(6) 2010 the patient presented with complaints of back pain and was administered lumbar epidural steroid injection at l4-5.
|
| |
|
Search Alerts/Recalls
|
|
|
