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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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| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Arthritis (1723); Asthma (1726); Dyspnea (1816); Fall (1848); Fatigue (1849); Fever (1858); Headache (1880); Hearing Loss (1882); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); Urinary Tract Infection (2120); Weakness (2145); Burning Sensation (2146); Chills (2191); Dizziness (2194); Myalgia (2238); Stenosis (2263); Anxiety (2328); Injury (2348); Depression (2361); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
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Event Type
Injury
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Event Description
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Procedure: posterior lumbar interbody fusion and anterior lumbar interbody fusion it was reported that on (b)(6) 2007, the patient underwent spine fusion surgery on the lumbar region at levels l5-s1.During the surgery, the patient was implanted with rhbmp-2 and collagen sponge.The rhbmp-2 collagen sponge was applied from posterior approach.The rhbmp-2 collagen sponge was placed outside a cage (i.E.In the posterolateral gutters).Post-op, the patient complained of chronic pain in her lower back and radiculopathy into her lower extremities, due to which patient underwent revision surgery.It was reported that the patient underwent spine fusion surgery on the lumbar region at levels l5-s1.During the surgery, the patient was implanted with rhbmp-2 and collagen sponge.Patient still continues to experience constant and severe low back pain that radiates to her buttocks and lower extremities.Patient has swelling in her right leg, radiculopathy in both legs, and experiences difficulty walking.Patient injuries prevented her from practicing daily life activities and reportedly the patient has suffered serious and permanent injuries.
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Manufacturer Narrative
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(b)(6).(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) 2010 the patient presented with following pre-op diagnosis: pseudoarthrosis at l5-s1.Status post posterior spinal fusion with instrumentation, decompression, and plif at l5-s1 performed on (b)(6) 2010 at an outside institution.The patient underwent: exploration of anterior spinal fusion from l5 to s1 with confirmation of pseudoarthrosis.Removal of plif cage performed through an anterior retroperitoneal approach.Revision of anterior spinal fusion from l5 to s1.Placement of anterior lumbar plate from l5 to s1 utilizing the plating system.Augmentation of anterior spinal fusion with rhbmp-2 and demineralized bone matrix.Spinal cord monitoring constituting of somatosensory evoked potentials and electromyography.As per op notes, once the fibrous tissue and the plif cage was removed.The peek cage system was used (an 8x 10 mm, 5 degree lordotic).The cage was therefore packed with 12mg rhbmp-2 on acs at 2.2 mg/ml graft volume concentration and was impacted in place.Fluoroscopy in both ap and lateral planes confirmed satisfactory placement of the instrumentation.There were no apparent complications.Intra-op findings: pseudoarthrosis at l5-s1.Fragmentation of the plif cage.On (b)(6) 2010 the patient underwent cervical transforaminal epidural steroid injection, at right c4-5 and c5-6 under fluoroscopy due to chronic pain, cervicobrachialgia, post-laminectomy syndrome; cervical.On (b)(6) 2010 the patient complained of severe right arm pain and stated her abdominal pain was much better than her neck and arm.On (b)(6) 2010 as per medical records, impression: vocal cord paresis.On (b)(6) 2010 the patient underwent x-ray of cervical spine.Impression: anterior c6-7 spinal fusion instrumentation shows no evidence of loosening or fracture.Anterolisthesis of c4 on c5 which shows 2 mm of placement on flexion and 2 mm of movement on extension.Mild narrowing of the central canal at c5.The patient underwent x-ray of lumbar spine.Impression: instrumented anterior and posterior l5-s1 spinal fusion procedure.Normal alignment of the lumbar spine.On (b)(6) 2010 the patient presented with following pre-op diagnosis: cervical spondylosis.Adjacent segment degeneration at c4-5.Status post acdf at c5-6 in 1985.Status post acdf at c6-7 in 1991.The patient underwent: removal of anterior cervical plate from c6-7.Exploration of anterior cervical fusion from c5-7 with confirmation of solid fusion.Complex anterior cervical discectomy at c4-5.Complex anterior cervical fusion from c4-5.Complex anterior cervical anterior cervical plating from c4 to c5 utilizing the titanium plating system.Placement of structural allograft at c4-5.Augmentation of anterior cervical fusion with morcellized local bone graft.Use of floor mounted operative microscope.Spinal cord monitoring consisting of somatosensory evoked potentials and transcranial motor evoked potentials.On (b)(6) 2010 the patient called stating that she "blacked out" about a week and a half ago (b)(6) 2010 the patient presented for xrays.Patient's arm still had some pain.Impression: instrumented anterior cervical discectomy fusion at c4-5, with healed c5-7 anterior fusion.Soft tissue drain has been removed with improvement in prevertebral soft tissue swelling.Combined anterior-posterior instrumented spinal fusion and decompression at l5-s1, unchanged in appearance from prior study.Diffuse lumbar degenerative disc disease, most severe at l1-2 and l2-3.On (b)(6) 2010 the patient complained of something made her feel woozy and foggy.On (b)(6) 2010, (b)(6) 2011, (b)(6) 2011 the patient presented for an office visit.Impression: satisfactory follow-up status post alif at l5-s1 performed on (b)(6) 2010.Satisfactory follow-up status post acdf at c4-5 performed on (b)(6) 2010.The patient underwent x-ray of cervical spine.Impression: no interval change in anterior cervical discectomy and fusion from c4 through c7.Persistent mild anterolisthesis of c4 on c5 that does not change with flexion or extension.No interval change in combined anterior and posterior instrumented fusion at l5-s1.Severe lumbar degenerative disc disease at l1-2 and l2-3, unchanged.On (b)(6) 2012, (b)(6) 2012 the patient presented with complaints of chronic back pain with radiation into the tailbone.She had back spasms, sleep disturbances, anxiety, depression, headaches, and difficulty lifting objects greater than 5 pounds, difficulty trying to sit for long and felt sick all the time.Ros: there were degenerative changes present at t12-l1, l1-l2, l2-l3 and to a lesser extent at l3-4 and l4-5.The patient underwent x-rays of cervical spine.Impression: unchanged discectomies and anterior fusion, c4-7 with anterior instrumentation at c4-5.There is no motion of the fused segments with flexion and extension.Unchanged laminectomies, discectomies and combined anterior and posterior instrumented fusion, l5-s1.There is no motion of the fused segments with flexion and extension.Unchanged multilevel lumbar degenerative disc disease and degenerative olisthesis.On (b)(6) 2014 the patient underwent ct scan of the lumbar spine.There were some mild degenerative changes elsewhere but no dominant lesion to include spinal stenosis or foraminal encroachment.Impression: post-laminectomy pain.On (b)(6) 2014 the patient presented for a follow-up with following symptoms: severe low back pain radiating down posterior left leg, burning sensation to posterior left leg, numbness to left buttock, occas right leg symptoms as well- radiating pain and numbness, increased weakness to bilateral legs over past week, balance issue when walking, extreme difficulty going up stairs and walking far distances to pain/weakness, denies b/b issues.Assessment: acute muscle spasm, focal spasm.On (b)(6) 2014 the patient had degenerative bone, asthma, osteoarthritis.On (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014: patient presented with bilateral low back, buttock and posterior thigh pain, neck back problems.Impression: cervicalgia, myalgia and myositis, neuralgia.On (b)(6) 2014 the patient had bilateral hip and back persistent pain.Impression: the right and left si joints were unremarkable.On (b)(6) 2014, (b)(6) 2014: patient underwent right sacroiliac joint arthrogram and steroid injection, with fluoroscopic guidance and contrast control.On (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014: patient presented for follow-up.On (b)(6) 2014 the patient underwent lumbar spine x-rays.Impression: degenerative changes.On (b)(6) 2014: patient presented for follow-up.Impression: lumbago, pain in joint, pelvic region and thigh, sacroiliitis, enthesopathy of hip region.On (b)(6) 2014: patient underwent lumbar spine 4 views.Impression: l5-s1 fusion possible fracture through cross linking horizontal rod.Spondylosis appears not significantly changed.On (b)(6) 2014: patient underwent left splenii levator scapulae trigger point injections under ultrasound guidance.On (b)(6) 2014 the patient underwent mri of cervical spine.Impression: surgical changes, spondylosis.On (b)(6) 2014, (b)(6) 2014: patient presented with left neck pain with numbness in left upper extremity.Impression: cervicalgia, myalgia and myositis, neuralgia.On (b)(4) 2014 the patient was diagnosed for left neck pain with radicular n/t in lue.On (b)(6) 2014: patient underwent cervical interlaminar epidural steroid injection at c6-7 under fluoroscopic guidance with contrast control.On (b)(6) 2014 the patient presented with chief complaint of bilateral neck and upper extremity pain.On (b)(6) 2014: patient presented with left neck pain with numbness in left upper extremity.Impression: cervicalgia, myalgia and myositis, neuralgia, lumbago, pain in joint, pelvic region and thigh, sacroiliitis, enthesopathy of hip region, cervical spondylosis without myelopathy.On (b)(6) 2014, (b)(6) 2014, (b)(6 )2014, (b)(6) 2014: patient presented with diagnostic block of the lateral branches/dorsal rami supplying the bilateral sacroiliac joint.On (b)(6) 2014: patient presented with bilateral low back pain and buttock pain with right side being worse.Impression: sacroiliitis, lumbago, spondylosis without myelopathy, pain in limb.On (b)(6) 2014: patient presented for follow-up.Impression: pain in joint, pelvic region and thigh, spondylosis without myelopathy, sacroiliitis.
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Event Description
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It was reported that on: (b)(6) 2010: the patient presented for follow up on lab tests.On (b)(6) 2011: the patient presented with lower back pain and possible kidney infection.On (b)(6) 2011: the patient presented for paperwork.On (b)(6) 2011: the patient presented with cough, back pain and recurrent ¿uti¿s¿.On (b)(6) 2011: the patient presented with cough.On (b)(6) 2012: the patient presented for paperwork.On (b)(6) 2013: the patient presented with fatigue, insomnia and arthralgias.On (b)(6) 2012, (b)(6) 2013: the patient underwent chest x-ray 2 view due to cough, shortness of breath and wheezing.Impression: no acute pulmonary disease.On (b)(6) 2012, (b)(6) 2013: the patient presented with cold symptoms.On (b)(6) 2014: the patient presented for office visit for swelling.The patient underwent ultrasound of lower extremity bilateral.Impression: no lower extremity deep venous thrombosis bilaterally.On (b)(6) 2013, (b)(6) 2014: the patient presented for back pain and neck pain.On (b)(6) 2014, the patient underwent ct scan of the lumbar spine due to low back pain.There were some mild degenerative changes elsewhere but no dominant lesion to include spinal stenosis or foraminal encroachment.Impression: post-laminectomy pain, some progression in lumbar spondylosis compared to 2008.On (b)(6) 2014, the patient presented with chief complaint of bilateral neck and upper extremity pain.The ¿emg¿ study of the patient indicated increased distal latencies of the bilateral median motor nerves and increased peak latencies of the bilateral median sensory nerves.On (b)(6) 2014: the patient presented for follow up on anxiety and lumbar degenerative disc disease.On (b)(6) 2015: the patient presented for follow up on anxiety, back pain and cold symptoms.On (b)(6) 2015: the patient presented for eye problems.On (b)(6) 2015: the patient presented for bp check and wheezing.On (b)(6) 2015: the patient presented for follow up on cold symptoms, bp check and lab tests.On (b)(6) 2015: the patient presented for follow up of hypertension and abdominal pain.On (b)(6) 2015, the patient underwent complete myelogram of spine.Impression: post surgical changes.No major canal stenosis.The patient underwent ct for thoracic lumbar.Impression; no major cord or canal compromise in the thoracic region.The patient underwent ct for cervical spine due to complaint of neck pain and upper right extremity radiculopathy, prior cervical fusion.Impression: mild scoliosis.Extensive prior fusion of c4- c7.Loss of cervical lordosis.The patient also had ct for lumbar spine.Impression: no major thecal narrowing.Some residual spondylotic changes.Patient underwent x-ray of cervical spine six views.Impression: stable post-op changes.Patient underwent x-ray of lumbar spine three views due to back pain.Impression: stable post-op changes; interval worsening of degenerative disc disease at l1-2 and l2-3.Patient underwent three views thoracic spine radiograph due to back pain.Impression: no acute abnormality.On (b)(6) 2015, the patient presented for follow up.The patient complaint of low back pain and couple of stumbling episodes.The patient also explained about shooting ¿star headaches with pain radiating down her upper extremity.On (b)(6) 2015: the patient was injected trochanteric bursa steroid under ultrasound guidance.On (b)(6) 2015: the patient presented for follow up on cough.On (b)(6) 2015, (b)(6) 2016: the patient presented for follow up of back pain, anxiety and hypertension.On (b)(6) 2015, (b)(6) 2016: the patient presented for follow-up.Impression: pain in joint- pelvic region and thigh, lumbago.On (b)(6) 2016: the patient presented for follow-up with chief complaint of low back pain.
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Manufacturer Narrative
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(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that on (b)(6) 2010, the patient had x-ray of right hand.Impression: dorsal soft tissue swelling of the right hand without underlying bone joint abnormally.On (b)(6) 2010.The patient presented for mri of right knee pain.Impression : horizontal tear in the posterior horn of the lateral meniscus; unchanged fraying of the free edge of the medial meniscus; tricompartmental degenerative osteoarthritis most severe and unchanged in the patellofernoral compartment.Cartilage is progressed in the medial and lateral compartments with a new near fullthickness cartilage defect at the posterior weight bearing lateral femoral condyte; stable changes of both medial and fibular collateral ligament injury; moderate joint effusion.No loose bodies identified in the current study; pes anserine bursitis.On (b)(6) 2010, the patient presented with right knee pain.The patient was found positive for swelling , anxiety , insomnia.On (b)(6) 2010, the patient presented with pre-op diagnosis of right knee medial and lateral meniscus tear and underwent following procedures: right knee arthroscopy , partial medial and lateral meniscectomy.Chondroplasty medial femoral condyle and the patellofemoral joint.On (b)(6) 2011, the patient presented with complaint of s/p right knee arthroscopy.On (b)(6) 2011, (b)(6) 2012, the patient was presented for office visit fro repeat clinical and radiographic evaluation following alif at l5-s1 performed in (b)(6) 2010 an acdf performed in (b)(6) 2010.The patient underwent x rays of the lumbosacral spine.Impression: unchanged instrumented anterior cervical discectomy and fusion at c4-5 and non-instrumented anterior cervical discectomy and fusion from c5 through c7; unchanged combined anterior and posterior spinal fusion at l5-s1 with l5 laminectomy; unchanged moderate lumbar spine degenerative disc disease from l1 through l3.The patient also underwent x rays of the cervical spine.On (b)(6) 2011: the patient presented with cough, back pain and recurrent ¿uti¿s¿.The patient was found positive for polyuria, back pain, chills and fever (b)(6) 2011: the patient presented with cough ,nasal drainage , ear around pain , sinus pressure, sore throat.On (b)(6) 2012, the patient presented with right knee osteoarthritis and pain.The patient underwent mri of right knee.Impression: severe patellofemoral chondrosis.Complex tear of medial meniscus.Partial meniscectomy of lateral meniscus.On (b)(6) 2012, the patient presented with right knee pain.Assessment : positive for hearing loss, anxiety.On (b)(6) 2012, the patient presented due to recurrent medial meniscus tear.Post op diagnosis were: recurrent medial and lateral meniscus tear.; chondromalacia ; osteoarthritis.On (b)(6) 2012, the patient presented with cough ,nasal drainage , ear around pain , sinus pressure, sore throat.
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