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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Catalog Number 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Fever (1858); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Dizziness (2194); Neck Pain (2433); Ambulation Difficulties (2544); Fibrosis (3167)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a procedure for posterior lumbar fusion at l4-l5 utilizing rhbmp-2/acs.Following surgery, the patient followed up with his physician.He began to develop severe back pain.The patient reportedly has never recovered from his surgery, and he continues to experience daily, disabling pain that prevents him from performing many basic activities of daily living.
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Manufacturer Narrative
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(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.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2015 <(>&<)> (b)(6) 2015, the patient presented with musculoskeletal pain in right shoulder.(b)(6) 2015, the patient presented for medicare preventive.
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Event Description
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It was reported that on (b)(6) 2015 per billing records, patient presented for an office visit.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2001 the patient presented with left knee problem.Assessment: left knee x one year, probable arthritis; gerd on (b)(6) 2007 the patient presented complaining of low back pain.Assessment: low back pain; gerd; uri.On (b)(6) 2008 the patient presented for medications refill.Assessment: gerd; osteoarthritis.On (b)(6) 2008 the patient presented with sinus pressure, headache, congestion, chills, and sneezing for clinical follow up.Assessment: sinusitis.On (b)(6) 2010 the patient presented for clinical follow up.The patient complains fo tenderness with palpation at the low back, mainly in the lumbosacral area.Assessment: chronic low back pain.Medications: toradol 60 mg, depo medrol 80 mg.On (b)(6) 2010 the patient presented for clinical follow up.Assessment: low back pain; health maintenance.On (b)(6) 2011 the patient presented for clinical follow up.Assessment: gerd; osteoarthritis.On (b)(6) 2011 the patient presented for clinical follow up.Assessment: osteoarthritis.On (b)(6) 2011 the patient underwent magnetic resonance imaging of the lumbar spine.Impression: small to moderate sized broad based left laterally protruding disc narrowing the left l4-5 neural foramen.On (b)(6) 2011 the patient underwent mri lumbar spine without contrast.Impression: degenerative disk disease with focal left paracentral disk protrusion at l4-l5 which contacts and displaces the descending left l5 nerve root.On (b)(6) 2011 the patient underwent ct of cervical spine without contrast, which demonstrated no acute fracture.The patient underwent ct of head without contrast, which demonstrated an unremarkable ct scan of the brain.The patient underwent ct of lumbar spine without contrast, which demonstrated moderate degenerative annular disc bulges the 3 lower lumbar levels.No acute fracture or disc herniation.The patient underwent mri of lumbar spine, which demonstrated progression of left paracentral disk protrusion at the l4-l5 level with an acute herniated component of a large disk extrusion.There was resultant severe spinal canal narrowing with rightward displacement of the descending nerve roots and mass effect upon the exiting left l4 nerve root, the remaining of the examination demonstrates multilevel degenerative disk disease without significant change.The patient underwent portable chest x-ray.Impression: no evidence of acute cardiopulmonary abnormality.The patient underwent x-ray of left hip.Impression: negative left hip.The patient underwent x-ray of pelvis.Impression: negative.The patient complained of injury to low back.On (b)(6) 2011 the patient presented with preop diagnosis of l4-5 traumatic herniated nucleus pulposus with severe central stenosis and radiculopathy.The patient underwent left l4-5 discectomy; transpedicular non-segmental hardware insertion, bilateral l4-l5; po sterior lateral arthrodesis at l4-5 using compression resistant matrix with bmp and local morselized bone graft.After taking the patient to operating room the thoracolumbar region was prepped and draped.Sub periosteal dissection was undertaken to dissect the paraspinal muscles from the spinous process and lamina of l3, l4 and l5 bilaterally.High speed drill was used to perform a medial facetectomy and inferior laminotomy at l4 and l5.It was noticed there was gross instability at the l4-5 segment.The dissection was then taken laterally, exposing the transverse processes of l4 and l5 bilaterally.A shard awl was used and the pedicle was sounded with a nim steffe probe with no abnormal discharge.The pedicle was then tapped, and solera multiaxial 6.5 mm screws were placed.Posterior lateral arthrodesis was completed using compression resistant matrix wrapped in infuse and augmented with morselized local bone graft.Medications: flexeril, medrol, meloxicam, naproxen, nexium, nucyrta.The patient underwent xr spine 1 view lumbar.Impression: surgical screws are now seen in projection with the l4 and l5 vertebrae.The patient underwent lumbar spine, portable ap view.(b)(6) 2011 the patient presented for follow-up with significant axial low back pain.The doctor advised the patient to continue the ongoing pain management.The patient underwent x-rays of lumbar spine, which demonstrated degenerative disc disease with posterior fusion at l4-5 level.On (b)(6) 2011 the patient underwent x-rays of lumbar spine with multiple views, which demonstrated posterior lumbar fusion at l4-5 with no evidence of hardware complication.Mild degenerative changes were noted, in comparison previous lumbar spine radiograph of (b)(6) 2011.On (b)(6) 2012 the patient presented with f/u back pain w/c, back pain and degenerative disc disease.Assessment: lumbago; osteoarthrosis.On (b)(6) 2012 the patient presented for follow-up with complaints of right hip and right leg pain.The patient underwent aquatic therapy on (b)(6) 2012 the patient presented for follow-up with complaints of back pain and right leg pain/radiculopathy.The doctor increased patient's neurontin as treatment.On (b)(6) 2012 the patient presented for follow-up with complaint of low back pain, the doctor's assessment was that the patient still struggles with chronic lbp and radiculopathy and advised him to continue fu with pain management.On (b)(6) 2012 the patient presented with complaint of back pain, the location of the pain was lower back.The pain radiated to the right leg and the patient described the pain as sharp and throbbing.The doctor's assessments were lumbago, lumbosacral spondylosis without myelopathy, ddd lumbar and osteoarthritis unspecified site.On (b)(6) 2012 the patient presented with flu shot and gerd.Assessment: gastroesophageal reflux; low back pain; arthropathy; immunization, influenza.Medications: meloxicam, nexium.On (b)(6) 2012 the patient underwent right sided transforaminal epidural steroid injection at l4-5 and l5-s1 due to back pain, lower extremity radiculopathy and ddd lumbar.On (b)(6) 2013 the patient presented with complaints of low back pain which has radiated to the left calf, left foot and left thigh.On (b)(6) 2013 the patient underwent caudal epidural steroid injection procedure due to degeneration of lumbar or lumbosacral intervertebral.On (b)(6) 2013 the patient underwent spinal cord stimulator trial due to lumbosacral spondylosis without myelopathy.The patient tolerated the procedure well.On (b)(6) 2013 the patient presented with complaints of low back pain, the doctor discussed the permanent implantation of a spinal cord stimulator as a possible modality for future care.On (b)(6) 2013 the patient presented with a pre-operative diagnosis of chronic low back pain, bilateral lower extremity radiculopathy, failed back surgery syndrome.The patient underwent spinal cord stimulator lead and generator implantation.On (b)(6) 2013 the patient underwent a boston scientific scs implant on (b)(6) 2013 and presented for post-surgery follow-up.The patient reported that the setting was fine.On (b)(6) 2013 the patient presented for scs reprogramming.The patient reported that he was getting better stimulation to his lower back and legs after reprogramming.On (b)(6) 2013, (b)(6) 2014, (b)(6) 2014 and (b)(6) 2014 the patient presented with complaints of back pain, the doctor's assessment was that the patient was doing well with his current medication and continued to assess the need for physical therapy, osteopathic manipulation therapy and injection therapy.On (b)(6) 2013 the patient presented with arthralgias and flu injection.Assessment: arthropathy; gastroesophageal reflux; routine general medical exam; benign prostatic hypertrophy.On (b)(6) 2014 the patient presented with gerd and arthralgias.Assessment: pain, shoulder; lumbago; gerd; bph; impaired glucose tole rance; hyperlipidemia; fatigue/malaise.The patient underwent x-ray of right shoulder.Conclusion: moderate right acromioclavicular join arthropathy.On (b)(6) 2014 the patient presented with arthralgias.The patient had injection today.Assessment: pain, shoulder.On (b)(6) 2014 the patient presented with complaint of right shoulder pain.The doctor's assessment was that the patient most likely has a rotator cuff tear.On (b)(6) 2014 the patient presented with pre-op diagnosis of right shoulder pain.The patient underwent right shoulder arthroscopic distal clavicle resection; right shoulder arthroscopic subacromial decompression.No patient complications were reported.On (b)(6) 2014 the patient underwent x-rays of chest pa and lateral, which demonstrated chronic interstitial changes present and no evidence of active disease.On (b)(6) 2014 the patient presented for follow-up.The doctor's assessment was that the patient was doing well and advised to continue hep with rom exercises and also advised to avoid any lifting for the next few weeks.On (b)(6) 2014 the patient underwent ct of lumbar, which demonstrated post surgical changes within the lumbar spine, multilevel degenerative disc disease, degenerative changes might impinge on the exiting right l3 nerve root on (b)(6) 2014, (b)(6) 2014, (b)(6) 2014 and (b)(6) 2014 the patient presented for follow-up with a complaint of low back pain, the doctor's assessments were degeneration of lumbar or lumbosacral intervertebral disc, lumbosacral spondylosis without myelopathy, osteoarthrosis , unspecified whether generalized or localized, involving unspecified site, lumbago.
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Manufacturer Narrative
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(b)(4).
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Event Description
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(b)(6) 2010: patient presented with complaint of congestion and cough.(b)(6) 2011: patient presented with the complaint of low back pain flare up from time to time.Diagnosis: low back pain with radiculopathy.(b)(6) 2011: patient underwent lumbar spine lt low back pain exam due to lumbar back pain.(b)(6) 2011: patient presented for follow-up on back pain.Patient stated pain is decreasing pain get worse when lying.Diagnosis: low back pain radiculopathy.(b)(6) 2011: patient presented for mri results.Patient stated he is still having pain but better going.(b)(6) 2011: the patient presented for follow up of back pain.Patient states pain is improved.Diagnosis: low back pain.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2011 the patient was diagnosed for lumbar strain, back pain, local injury affecting low back.On (b)(6) 2011 the patient also underwent ct of cervical spine without contrast, which demonstrated no acute fracture, no displacement or subluxation.On (b)(6) 2012 as per medical record, the patient has gait disturbance and back pain.Assessment: degenerative disc disease.On (b)(6) 2012 the patient underwent x-ray pa chest for pneumoconiosis chest film interpretation.Impression: coal worker's pneumoconiosis, category p/q, 2/1, pi.Mild scoliosis.On (b)(6) 2012 the patient underwent an ilo reading.On (b)(6) 2012 the patient came for an office visit due to back pain, radiating pain in his right hip and leg and some lateral pain in his left leg ankle.The physical examination revealed pulling sensation in the lower back on extension of right knee, slightly diminished right ankle reflexes and back pain at 45 degrees in the supine position.The patient had a midline lumbar scar and resisted lateral flexion.On (b)(6) 2012 the patient underwent a hearing exam.On (b)(6) 2013 the patient came for an office visit with chronic pain status post l4-l5 lumbar discectomy.The patient was diagnosed for anxiety disorder nos and orthopedic injury.(b)(6) 2013: the patient came for an office visit due to back pain.The musculoskeletal examination revealed antalgic gait, tenderness and moderate pain w/motion in lumbar spine.Assessment: lumbosacral spondylosis without myelopathy, degeneration of lumbar or lumbosacral intervertebra, osteoarthritis unspecified site, lumbago and post laminectomy syndrome lumbar.(b)(6) 2013 the patient presented with back and leg pain.Patient described pain as aching, burning, deep, piercing, sharp, shooting, stabbing and throbbing.The musculoskeletal examination revealed tenderness and moderate pain w/motion in lumbar spine.Assessment: lumbosacral spondylosis without myelopathy, degeneration of lumbar or lumbosacral intervertebral, osteoarthritis unspecified site, lumbago and post laminectomy syndrome lumbar.On (b)(6) 2013 assessment: lumbosacral spondylosis without myelopathy, degeneration of lumbar or lumbosacral intervertebral, osteoarthritis unspecified site, lumbago and post laminectomy syndrome lumbar.On (b)(6) 2013 the patient presented with complaints of hearing loss.Diagnostic reports indicated severe high frequency sensorineural hearing loss bilaterally.On (b)(6) 2013 the patient presented with back pain that is radiating into his right hip and leg aggravated by standing or walking and some pain in the outside of his left leg.The physical examination revealed pulling sensation in the lower back on extension of right knee, slightly diminished right ankle reflexes and back pain at 45 degrees in the supine position.The patient had a midline lumbar scar and resisted lateral flexion.On (b)(6) 2013 as per medical records, the review of systems was positive for anxiety, insomnia, back pain, joint pain and neck pain.The musculoskeletal examination revealed tenderness and moderate pain w/motion in lumbar spine.Assessment: lumbosacral spondylosis without myelopathy, degeneration of lumbar or lumbosacral intervertebral, osteoarthritis unspecified site, lumbago and post laminectomy syndrome lumbar.On (b)(6) 2013 the musculoskeletal examination of the patient revealed antalgic gait and moderate pain w/motion in lumbar spine.Assessment: lumbosacral spondylosis without myelopathy, degeneration of lumbar or lumbosacral intervertebral, osteoarthritis unspecified site, lumbago and post laminectomy syndrome lumbar.The patient underwent spinal cord stimulator reprogramming with rep from boston scientific.On (b)(6) 2013 the patient underwent independent medical examination.Findings: considerable level of functional disability, moderately high level of reactive muscular tension, high level of anxious thoughts and feeling.On (b)(6) 2013 the patient came for an office visit.The review of systems indicated pain distribution in the mid and low back, radiating into the right hip and right thigh, as apparently the surgery removed the left leg pain.Positive for inability to lie down very long due to back pain.(b)(6) 2014 the patient came for an office visit with single pa chest x-ray.Impressions: no evidence of coal-worker's pneumoconiosis.The ilo classification is 0/0.Healed granulomatous disease.(b)(6) 2015 the patient presented with 4 years history of dyspnea and chest pain with exertion and coughs that is productive of black sputum.The patient was diagnosed for plaintiff's disease due to exposure to coal dust in the severance or processing of coal.The patient underwent chest x-ray.Findings: 2/1 pneumoconiosis.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2015 the patient presented with a history of joint pain and underwent x-rays of the right knee.On (b)(6) 2012: patient presented with back and right lower extremity pain and status post l4-l5 plif.Patient had pain into his right lower extremity which he described into the anterolateral aspect of the right lower leg and over dorsum of the foot.It was burning pain and persistent.Back examination revealed a bit of tenderness over his back and decreased sensation over the right l5 dermatome.Patient underwent spine x-ray which demonstrated stable configuration of the 4-5 construct.No complicating features were identified.Assessment: evidence of right l5 radiculopathy.Sensory conduction study was completed for the right sural nerve which demonstrated normal latency and amplitude.Motor conduction study was completed for the peroneal nerve in the right lower extremity which demonstrated normal latency amplitude and nerve conduction velocity.Summary: the above electrodiagnostic study is mildly abnormal.There is old injury pattern of the left l5 versus peroneal nerve.The pattern shows recovery.There are no findings consistent with acute radiculopathy, plexopathy, neuropathy and entrapment.On (b)(6) 2012: patient presented for follow up after myelogram/post myelogram ct and nerve conduction studies of the right lower extremity.Emg/nerve conduction study demonstrated an old injury pattern of the left l5 nerve root.This pattern however showed electrophysiologic recovery.Current placement of the transpedicular screws appeared intact with decompression at the 4-5 segment level.On (b)(6) 2012: patient presented for routine follow up and review of myelogram/post myelogram ct.On (b)(6) 2001: patient underwent x-ray of left knee.On (b)(6) 2003: the patient presented with a 2 weeks history of generalized fever, aches, cough productive of yellow sputum and dizzi ness when he bends over.Assessment: flu syndrome, bronchitis.Patient underwent x-ray of pa and lateral chest.On (b)(6) 2007: patient underwent x-ray of lumbosacral spine.On (b)(6) 2011: patient presented for medication refills.Assessment: gerd, osteoarthritis.On (b)(6) 2015: the patient presented for uri.Assessment: bronchitis.Diagnosis: cr shoulder 2 views right.On (b)(6) 2015: the patient presented with musculoskeletal pain and gerd.Diagnosis: cr shoulder 2 views right.On (b)(6) 2015: the patient presented with musculoskeletal pain and gerd.Diagnosis: cr shoulder 2 views right and cr knee 3 views right.
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Manufacturer Narrative
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(b)(4).
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Event Description
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On (b)(6) 2012 the patient underwent ct scan of lumbar spine due to bilateral leg pain.Impression: 1.Interval l4-5 surgical resection and posterior fusion without obvious complicating features; 2.Spondylosis, facet joint arthropathy, and ligamentum flavum hypertrophy at l4-5 and l5-s1 without significant central canal stenosis and only mild to moderate bilateral l5-s1 neural foraminal narrowing.The patient also underwent lumbar myelogram.Impression: 1.L4-l5 post surgical changes without indication of misalignment or complication; 2.Mild degenerative disc changes at l3-l4 through l5-s1.No subluxation upon flexion/ extension views.On (b)(6) 2014 the patient presented post right shoulder arthroscopic surgery for clean up.Prior level of function was painful, limited right shoulder motion that affected daily activities.Treating diagnosis: disorders of bursae and tendons in shoulder region, adhesive capsulitis of shoulder, aftercare following surgery of the musculoskeletal system.Assessment: patient is status post bore spur removal and shoulder clean up procedure.He demonstrates good potential to improve.Interventions provided: initial evaluation pt (97001) for 20 min, therapeutic exercise (97110) for 45 min, manual therapy (97140) for 15 min.On (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014 patient presented for follow-up, patient reports his shoulder is doing good.Reported no pain in this session.Patient underwent therapeutic therapy and manual therapy.Assessment: the patient was able to successfully complete additions and progress to the treatment program without a reported increase in pain.The patient requires skilled, focused functional strengthening to improve functional abilities for performing.(b)(6) 2011: the patient presented with complaint of low back pain radiating down to left leg.The patient underwent mri of lumbar spine due to history of low back pain.Impression: small to moderate-sized broad based left laterally protruding disc narrowing the left l4-5 neural foramen.(b)(6) 2011: the patient presented with chief complaint of backache.(b)(6) 2011: patient presented with low back pain and tingling in left leg.Patient underwent funduscopic exam.Musculoskeletal review revealed slight pain on flexion, extension of lumbar spine.Review of mri revealed severe disc degenerative disease at l4-5 and l5-s1.On (b)(6) 2011 patient presented with diagnosis of acute herniated nucleus pulposus with severe intractable back and leg pain.Patient involved in mining accident.As a result, patient was unable to walk secondary to severe back pain and severe leg pain that radiated down to top of his foot.Musculoskeletal review revealed severe point tenderness of mid lower lumbar spine.Assessment: acute herniated nucleus pulposus, post trauma with severe back pain and radiculopathy.(b)(6) 2011: patient presented with right hip and leg pain.(b)(6) 2011 patient presented with admit diagnosis of lumbar degenerative disc disease.The patient also underwent for x-ray of lumb ar degenerative disc disease.Impression: degenerative disk disease with posterior fusion at the l4-l5 level.(b)(6) 2011: the patient was presented with following admit diagnosis: lumbago.Patient also presented with axial back pain.Review of lumbar spine radiographs revealed good position for hardware and graft.It appeared that he is developing a posterior lateral fusion.(b)(6) 2011: patient presented with constant back pain and leg pain, lumbar ddd.There was tenderness to palpation along incision.(b)(6) 2012: patient presented with diagnosis of lumbar ddd and status post lumbar fusion.Patient underwent therapeutic exercises, aquatic therapy and electric simulation.(b)(6) 2012: patient presented with pain and reported that pain complaint has not changed since evaluation.(b)(6) 2012: patient also presented with axial back pain and paraspinal muscle spasms.Musculoskeletal review revealed severe discomfort for lumbar spine range of motion.(b)(6) 2012: patient presented with back pain.Diagnostic impression: back pain.(b)(6) 2012: patient presented with low back pain and right leg pain.(b)(6) 2012: the patient presented for a follow-up visit with complaint of low back pain and had difficulty with ambulation.(b)(6) 2012: patient presented with chronic back pain with radiations into the hips and legs.(b)(6) 2012: patient presented with back, hip and leg pain.Patient described pain as aching, sharp, stabbing and throbbing.(b)(6) 2012: the patient presented for an office visit with complaint of back pain.Assessment: lumbosacral spondylosis without myelopathy, degeneration of lumbar or lumbosacral intervertebr, osteoarthritis unspecified site.(b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2013, (b)(6) 2013, and (b)(6) 2013: patient presented for an office visit for scs implant follow-up with complaint of back pain.Assessment: lumbosacral spondylosis without myelopathy, degeneration of lumbar or lumbosacral intervertebr, osteoarthritis unspecified site; lumbago (b)(6) 2013: patient presented with back & leg pain.(b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2014: patient presented with back and leg pain.Patient described pain as aching, burning, deep, piercing, sharp, shooting, stabbing and throbbing.(b)(6) 2013: the patient was presented with following admit diagnosis: lumbosacral spondylosis and underwent for urine culture.(b)(6) 2014: the patient presented with complaint of right shoulder pain.Assessment: rotator cuff tear (b)(6) 2014: the patient presented for follow-up for right shoulder status post-op.Assessment: shoulder impingement.(b)(6) 2014: the patient presented for post-op follow-up for right shoulder and reported some pain.(b)(6) 2015: the patient presented with complaint of low back pain which occurred persistently.Pain radiated to the right calf, right foot and right thigh.(b)(6) 2015: the patient presented with complaint of low back pain.Location of pain was lower back and right leg.(b)(6) 2015: the patient presented with complaint of low back pain and chronic pain.Assessment: rotator cuff (capsule) sprain; shoulder impingement.
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Event Description
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It was reported that on (b)(6) 2012:per billing records, patient underwent x-ray.(b)(6) 2014: patient underwent x-ray of the chest.Impression: subcentimeter bilateral noncalcified pulmonary nodules more numerous on the right as detailed above.The nodules were nonspecific in ct appearance, with both noncalcified granulomas and metastatic disease being within the differential.Pulmonary evaluation was warranted.These nodules were likely too small for further evaluation by imaging at this time or imaging directed biopsy.The lungs were free of consolidative infiltrates or effusions.Patient underwent x-ray of the ap and lateral lumbar spine.Impression: normal.
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