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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 7510400 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Wound Dehiscence (1154); Ossification (1428); Cyst(s) (1800); Edema (1820); Unspecified Infection (1930); Irritation (1941); Nausea (1970); Neuropathy (1983); Pain (1994); Scarring (2061); Swelling (2091); Vomiting (2144); Burning Sensation (2146); Discharge (2225); Stenosis (2263); Anxiety (2328); Neck Pain (2433); Post Operative Wound Infection (2446); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651)
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Event Type
Injury
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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.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.
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Event Description
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It was reported that the patient underwent an oblique lumbar interbody fusion procedure at l4 to s1 using rhbmp-2/acs on (b)(6) 2006.Patient's post-operative period has been marked by severe lower back pain with radiation into his lower extremities.It was reported that since his initial surgery, patient has undergone three revision surgeries to repair his fusion and remove bony overgrowth from his spine.A lumbar ct myelogram performed on (b)(6) 2012, confirmed a neurocompressive lesion at the implant site.
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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) 2006: pre-op diagnosis: degenerative disk, l4-5, l5-s1, lateral recess stenosis.Procedure: right l4-5, l5-s1 oblique lumbar interbody fusion.Left l4-5, l5-s1 onlay fusion, lateral mass technique.Pedicle screw reconstruction, l4 through s1.Right facetectomy, foraminotomy, microdissection, l4-5 and l5-s1.Left foraminotomy, l4-5, l5-s1.Intraoperative fluoroscopy, intraoperative microdissection, epidural steroids, interbody grafts times two.The 13 mm structural machine allograft.Preop notes: patient was taken to operating room and placed under endotracheal anesthesia.Fluoro was inserted into the field in both planes.A midline incision was marked with fluoro.Fluoro was used to apply pedicle screws at l4, l5.Preparation for a 13 mm graft template was done.A complete discectomy was achieved and plates were decorticated.The 13 mm structural machine allograft was applied at l4-5 and l5-s1.(b)(6) 2006: pre-op diagnosis: instability, pedicle screw instrumentation, status post multilevel lumbar fusion.Procedure: exploration fusion, disassembly, posterior segment instrumentation.Orlay bone graft, lateral mass technique, dorsal micline osteocell.(b)(6) 2007: patient under went ap and lateral x-ray.Impression: status post l4 through s1 oblique lumbar interbody fusion with loose sacral screw and the cross link detached from left side.(b)(6) 2007: patient under went mri of the lumbar spine.Impressions: focal broad based disc herniation at the posterolateral aspect of the l5-s1 disc, which in conjunction with degenerative facet hypertrophy at this level, continues to moderate to severe right neuroforaminal encroachment at l5-s1.Mild to moderate left neuroforaminal encroachment at l5-s1 secondary to disc bulging and mainly facet hypertrophy.Moderate right neuroforaminal encroachment at l4-l5 and milder left neuroforaminal encroachment at l4-l5 secondary to disc bulging and facet hypertrophy.Surgical fusion with pedicle screws and posterior rods from l3 through s1.Intervertebral spacer implants at l4-l5 and l5-s1.There is right lateral recess and right neuroforamen at l5-s1 level.No abnormal areas of contrast enhancement and no abnormal fluid collection.(b)(6) 2008: patient presented for follow up.He has progressive severe left lower extremity pain which is residual on left side.Patient was recommended exploration of minimally invasive approach, removal of hardware and foraminotomy left sidel4-l5, l5-s1.(b)(6) 2008: pre-op diagnosis: far lateral recess stenosis l4-l5 and l5-s1 left side, rule out pseudoarthrosis and instrumentation failure.Procedure: removal of instrumentation l4-s1.Exploration of fusion l4-s1, no pseudoarthrosis found.Facetectomy and foraminotomy, left l4-l5 and left l5-s1.Intra-operative microdissection.Intraoperative fluoroscopy, lateral plane.Epidural steroids.(b)(6) 2008: the patient presented for follow up, status post l4 through s1 hardware removal and assessment of fusion and the left l4-l5 and l5-s1 foraminotomies.Patient has increased pain in left hip areas, left thigh area, consistent with nerve swelling.Some drainage in incision is also reported.Impressions: status post hardware removal l2 to s1 with left l4-l5 and l5-s1 foraminotomies.Postop wound drainage, with a small dehiscence.(b)(6) 2008: patient presented for follow up because of lumbar wound drainage and foul smelling discharge.Patient visited (b)(6) hospital with a wound, there was some purulence when this was packed and wound was down deep to the fascia.Recommendations: blood cultures.Picc line.Daptomycin 6 mg/kg every 24 hours.(b)(6) 2008: patient presented for follow up and is advised for surgical closure of his wound.(b)(6) 2008: patient presented for follow up, complains of left lower radiculopathy which could be some residual from nerve irritation.(b)(6) 2008: patient under went mr lumbar spine with and without contrast.Impressions: improving soft tissue edema and fluid posterior to l3-l5.Small recurrent disc protrusion seen on the right l5-s1 may be narrowing the right l5-s1 foramen and lateral recess.No evidence of disc space infection or vertebral edema.(b)(6) 2008: patient presented for follow up, patient is progressing, patient still has his left lower radiculopathy.Impression: status post removal of hardware l2 to s1, foraminotomies at l4 to s1 on the left.(b)(6) 2008: patient presented for follow up for his lumbar condition and postoperative wound infection.Patient complaints of left lower back, left sacral and left buttock pain.(b)(6) 2008: patient under went xr l-spine 2 or 3 vw.Impressions: postsurgical changes at l4-5 and l5-s1, previously seen metallic screws have been removed from the pedicles (when compared with previous mri dated (b)(6) 2007).(b)(6) 2008: patient presented for follow up for his lumbar condition.Patient has significant low back pain and left posterior thigh pain.Impression: status post l4 through s1 oblique lumbar interbody fusion with failed back surgery syndrome, neuropathic pain, rule out small fracture of fusion mass.(b)(6) 2009: patient presented for follow up after one year, patient has low back pain and electrical shooting pains down the left posterior thigh into the calf.Impression: status post l4 through s1 oblique lumbar interbody fusion with failed back surgery syndrome, neuropathic pain, rule out small fracture of fusion mass.(b)(6) 2009: patient under went ct spine w/3d recon.Impressions: status post intervertebral body metallic cages l4-l5, l5-s1 level.Multiple level degenerative disc disease, facet disease, most severely at l5-s1.(b)(6) 2009: patient presented for follow up, patient comes with back pain and left lower radiculopathy down to the posterior thigh to his foot.Patient under went ct scan.Impression: mild central disc at l3-4, bilateral foraminal stenosis, right greater than left at l4-5, severe right lateral recess and moderate left at l5-s1.(b)(6) 2010: patient under went a mri of the lumbar spine.Impressions: at l1-2 and l2-3, there are bilateral facet osteophytes.A t l3-4, there is disc bulging with bilateral facet osteophytes.At l4-5, there is evidence of previous lumbar spine surgery with magnetic artifact over the disc space.Shallow broad based disc herniation with circumferential bulging and disc and facet osteophytes.Disc herniation extends into neural foramina.Causing an anterior impression on thecal sac.At l5-s1, there is disc herniation, which extends from midline into the right neural foramen, which is superimposed on circumferential bulging with disc and facet osteophyted.(b)(6) 2010: patient under went ct lumbar spine w/o contrast with 3-d reformatted images.Impressions: l5-s1, interval diminishment but not resolution of vacuum phenomena.Right subarticular recess is narrowed by facet joint overgrowth and osteophyte formation.L4-5, and interbody fixating device appears incorporated into the inferior endplate.Facet joints show solid ankylosis.(b)(6) 2010: patient visited for follow up, patient has right and left s1 radiculopathy bilaterally.Patient has a mechanical component to his pain.Impression: a heterotopic bone growth at right l5-s1 foramen.(b)(6) 2010: patient under went a chest 2 views x-ray.Impressions: no acute pulmonary disease.(b)(6) 2010: pre-op diagnosis: bilateral l5-s1 lateral recessed stenosis, heterotopic bone.Rule out pseudoarthrosis.Procedure: bi lateral redo facetectomy, foraminotomy, l5-s1, resection of scar microsurgical, bilateral onlay fusion with dbm 30 cc allograft.Intraoperative fluoroscopy lateral plane.Intraoperative microdissection.Epidural steroids methylprednisolone 80 mg.Patient under went a single view lumbar spine x-ray.Impressions: skin retractors are present.There is a marker projecting posterior to the lumbar spine at l5 level.(b)(6) 2010: patient visited for follow up, patient is progressing well.(b)(6) 2011: pre-op diagnosis: persistent, severe low back pain.Severe lumbar radiculopathy, lumbar disc disease.Procedure: insertion of right and left sided bionic epidural electrode eight lead for trial of dorsal column stimulation to assess benefit.Intraoperative and post-operative programming of bilateral epidural leads by bionic.(b)(6) 2011, (b)(6) 2012, (b)(6) 2013: patient presented with low back pain and left leg pain.(b)(6) 2012: patient visited for follow up, in regards of pain in his low back.(b)(6) 2014: patient under went ct scan of lumbar spine.Impressions: no demonstrated compression deformity, osteopenia.Broad-based disc bulge at l3-l4.There is previous decompressive laminectomy.Interbody fusion at l4-l5 and decompressive laminectomy.There is eccentric left pars defect without listhesis.5mm anterolisthesis at l5-s1.Pseudo disc bulge and facet hypertrophy narrowing the neural foramina with nerve root impingement.Bilateral pars defects without listhesis.Ivc filter in place.
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Event Description
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It was reported that on (b)(6) 2008: pre-op diagnosis: far lateral recess stenosis l4-l5 and l5-s1 left side, rule out pseudoarthrosis and instrumentation failure.Procedure: removal of instrumentation l4-s1.Exploration of fusion l4-s1, no pseudoarthrosis found.Facetectomy and foraminotomy, left l4-l5 and left l5-s1.Intra-operative microdissection.Intraoperative fluoroscopy, lateral plane.Epidural steroids.The patient underwent radiographic study of lumbar spine.Impression: inter-body fusion device.No metallic hardware was seen.On (b)(6) 2008: the patient was discharged.On (b)(6) 2008: patient presented for follow up because of lumbar wound drainage and foul smelling discharge.Patient visited hospital with a wound, there was some purulence when this was packed and wound was down deep to the fascia.Recommendations: blood cultures.Picc line.Daptomycin 6 mg/kg every 24 hours.The patient underwent x-ray of chest to verify the left arm ¿picc¿ line placement.Impression: picc line tip ends rear the junction or the superior vena cava and the right atrium.No pneumothorax is seen.The course of the picc line is located well above the top of the left glenoic over the top of the left shoulder.On (b)(6) 2008: the patient presented for an office visit with chief complaint of severe low back pain.The patient underwent review of systems and physical examinations.Impression: non-healing post-operative wound, staphylococcus auricularis bacteremia, intractable low back pain, status post multiple low back surgeries, hypertension, history of prostate cancer, asthma in remission, smoker, diarrhea, clostridium difficile, and obesity.On (b)(6) 2008: the patient underwent pre and post contrast imaging of chest for comparison with pre-operative study of (b)(6) 2006.Impression: post-operative changes with hardware removal.Large fluid collection in para-spinous tissues with tracking or additional fluid collection adjacent to spinous process or left probably communicating.Enhancing tissues l5-s1 within spinal canal on right scar versus inflammatory process.Mild bone marrow edema s1, l5, l4, non-specific.Linear enhancing tract associated with posterior lateral l4-l5 disc adjacent facet joint on right likely post-surgical.Abundant intra-spinal fat in comparison to (b)(6) 2006.Progressive mild disc bulging l3-l4, l4-l5 and l5-s1.On (b)(6) 2008: the patient presented for an office visit due to history of low back pain and infection.Ct was performed for fusion evaluation.Impression: incomplete bony fusion associated with intra-ciscal material l5-s1.Small amount of air at disc space, non-specific.Absence of bony fusion associated with disc space l4-l5.Extensive posterior element post-surgical changes and degenerative changes.On (b)(6) 2008: the patient underwent x-ray of chest for comparison with the results obtained on (b)(6) 2008.Impression: right arm picc line tip over svc.On (b)(6) 2008: the patient was discharged (b)(6) 2008: the patient was discharged.On (b)(6) 2010: the patient presented for office visit for medical management issues.On (b)(6) 2011: patient presented with complaint of low back pain, left leg pain.Impression: low back pain; left leg pain; lumbar disc disease; lumbar radiculopathy.On (b)(6) 2011: patient underwent chest radiograph pa and lateral.Impression: negative limited chest radiograph.On (b)(6) 2011: patient presented complaint of severe amount of lower back pain that radiated to legs.Assessment: failed back syndrome, status post spinal cord stimulator trial.On (b)(6) 2011: patient underwent x-ray of thoracic spine due to pain.Impression: compression deformities of t11 and t12 of indeterminate age; degenerative lower thoracic spondylosis.On (b)(6) 2011: patient presented with pre-op diagnosis as: chronic lumbar spine pain, chronic lumbar radiculopathy.For which patient underwent bilateral laminectomy att9-t10, placement of dorsal column stimulator paddle.On (b)(6) 2011: patient presented for an office visit status one week post dorsal column spinal cord stimulator paddle placement complaining of having some pain over the region.Assessment: one week status post spinal cord stimulator paddle replacement.On (b)(6) 2012: patient presented with complaint of left-sided low back pain that has been progressively worsening over the last two months.Impression: left sided low back pain, history of spinal cord stimulator placed on (b)(6) 2011 with history of prior lumbar spinal fusion.On (b)(6) 2012: patient underwent ¿ir¿ myelogram lumbar due to low back pain.Impression: uncomplicated successful contrast injection.Minimal ventral extradural defects l1-3.3.Probable lower lumbar fusion material l4-s1.On (b)(6) 2013: as per billing records, patient underwent chest x-ray.On (b)(6) 2013: patient presented with following pre-op diagnosis: failed lumbar spine surgery, lumbar pseudoarthrosis, lumbar radiculopathy, lumbar stenosis and failed spinal cord stimulator paddle and obesity.For which patient underwent: escharectomy; revision bilateral laminectomy, l3-s1; bilateral complete facetectomy, l4-l5 and l5-s1; bilateral foraminotomy, l4-l5 and l5-s1; bilateral posterior segmental instrumentation, l4-s1; harvest of iliac crest local autograft; bilateral posterior spinal fusion, l4-s1; revision bilateral laminectomy, t9-t10; removal of spinal cord stimulator, thoracic spine; removal of battery pack spinal cord stimulator.Patient tolerated the procedure well without any intraoperative complications.On (b)(6) 2013: patient presented with complaint of low back pain.Assessment: status post revision lumbar laminectomy and fusion at l4 to s1.On (b)(6) 2013: patient presented for patient evaluation and underwent therapeutic exercises.On (b)(6) 2013: patient presented for follow up six months status post fusion, l4 to s1.Assessment: status post revision laminectomy and fusion, l4 to s1.On (b)(6) 2013: patient presented with complaint of recurrent low back pain and right lower extremity pain.Patient x-ray showed instrumentation within good position.No subluxation or fractures.(b)(6) 2014: patient underwent ct of the cervical spine without contrast due to history of chronic neck pain, rear end collision 44 years ago.Impression: levoscoliosis with osteopenia and multisegmental cervical spondylosis.No acute compression or segmental motion.Multi-segment degenerative anterior endplate osteophytes.Posterior disc-osteophytic complex c5-6 compressing the ventral thecal sac.Accompanying facet hypertrophy contributing to foraminal narrowing and nerve root impingement, left worse than right.3.Posterior bulge of the cortex at t1 contributing to central stenosis and of indeterminate etiology.On (b)(6) 2014: patient underwent x-ray of lumbar spine.Impression: status post revision lumbar laminectomy and fusion, removal of spinal cord stimulator.On (b)(6) 2015: the patient presented with low back pain with lumbar radiculopathy.
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Manufacturer Narrative
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Additional information: event or problem, relevant tests/lab data, other relevant history, evaluation codes.(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) 2007: the patient underwent ct of the lumbar spine due to lumbar pain.Impression: post-surgical changes with plate and screws transfixing the l4, l5, and s1 levels.There are cage devices in place at the l4-5 and l5-s1 levels.Schmorl's nodes demonstrated at the l4-5 level.Mild articular facet bilaterally at the l3-4 and l4-5 levels resulting in mild foraminal narrowing bilaterally.On (b)(6) 2007, patient presented for office visit with history of longstanding back problems.Patient reported constant pain in back, burning, stabbing aggravated by coughing, lifting, prolonged sitting, standing, bending over, leaning backwards, stress and walking, patient has difficulty in sleeping at night and anxiety.Mri from (b)(6) 2006 showed multiple hemangiomas and there were reactive endplate changes at l5-s1, multilevel disc desiccation, mild bulge l3-4, mild facet disease, ligamentum hypertrophy l3-4 and l4-5 there is mild bulge, moderate facet degenerative changes with mild to moderate right and mild left-sided neuroforaminal narrowing.On (b)(6) 2007, patient presented for follow-up visit with complaint of low back pain.On (b)(6) 2007, patient underwent following procedure: caudal epidural steroid injection, impression: successful caudal epidural injection.On (b)(6) 2007, patient underwent mri of right knee without contrast.Impression: no meniscal tear or ligamentous tear at the right knee; small joint effusion; there is a component of osteoarthritis at the patellofemoral joint with advanced patellar chondromalacia and minimal spurring.Patient underwent mri of left knee without contrast.Impression: moderate to large joint effusion at left knee; no meniscal tear or ligamentous tear; small popliteal cyst.Patient underwent following procedure: interlaminar l3-4 epidural steroid injection.Impression: successful interlaminar l3-4 epidural steroid injection.On (b)(6) 2008: patient presented for follow up of infected wound post op.On (b)(6) 2008: patient presented for follow up on infected wound post op to back.Patient complains of pain to left knee and his back.On physical examination of spine there are scars consistent with previous injuries.Back has a cavity with some drainage.The cavity itself is smaller although still is quite deep.There is no surrounding redness.The left knee shows some swelling with joint effusion.Impression :post operative infection.On (b)(6) 2008: patient presented with diagnosis of post operative infection of lower back.Complains of pain to bilateral hip /leg and lower back.Patient with bilateral lower extremity edema.On (b)(6) 2008: patient presented for follow up of post operative wound infection of back.Impression: chronic osteomyelitis, djd:status: resolved.On (b)(6) 2009, patient underwent following procedure: third orthovisc injection due to left knee osteoarthritis.No complications were reported.On (b)(6) 2007, (b)(6) 2008, (b)(6) 2009, (b)(6) 2010, patient presented for follow-up visit with chief complaint of low back and knee pain.On (b)(6) 2010: pre-op diagnosis: bilateral l5-s1 lateral recessed stenosis, heterotopic bone.Rule out pseudoarthrosis.Post-op diagn osis: bilateral lateral recess stenosis with immature and thin fusion and severe lateral recessed stenosis at l5-s1.Procedure: bilateral redo facetectomy, foraminotomy, l5-s1, resection of scar microsurgical, bilateral onlay fusion with dbm 30 cc allograft.Intrao perative fluoroscopy lateral plane.Intraoperative microdissection.Epidural steroids methylprednisolone 80 mg.Patient under went a single view lumbar spine x-ray.Impressions: skin retractors are present.There is a marker projecting posterior to the lumbar spine at l5 level.On (b)(6) 2010 patient presented for follow-up visit with chief complaint of low back, nausea and vomiting.On (b)(6) 2016: patient presented for office visit and underwent lumbar/sacroiliac joint injection.
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Manufacturer Narrative
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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) 2013: patient presented with low back pain and left leg pain.On (b)(6) 2014: the patient was pre-operatively diagnosed with low back pain and underwent: auricular percutaneous neurostimulator implant of non programmable generator and electrode system applicable auricular neural bundle 3 electrodes; auricular branch of vagus nerve and auriculotemporal nerve accessed via electrode implanted in nerve site; analysis of neurostimulator device operation and neuro stimulator device placement.On (b)(6) 2014: patient presented with low back pain and left leg pain.
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