MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number	7510050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
It was reported that on: (b)(6) 2010: the patient was pre-operatively diagnosed with cervical spinal stenosis c5-c6 and cervical disk herniation at c5-c6.Patient underwent following procedures : anterior cervical diskectomy, c5-c6; anterior cervical fusion using auto and allograft; placement of anterior interbody cage; placement of anterior cervical instrumentation.Also patient complained of acute pain and infection risk, underwent muscoskeletal, neuro exam.Impressions: interoperative lateral view shows anterior fusion at c5-c6.Patient underwent surgery using rhbmp-2/acs.The patient underwent neuro and musculoskeletal exam.(b)(6).The patient presented for follow up visit at the hospital.(b)(6) 2010 (date is approx.): the patient was pre-operatively diagnosed with l3-l4, l4-l5 degenerative disk disease and l3-l4, l4-l5 degenerative lumbar spinal stenosis and underwent following procedures: l3-l4, l4-l5 direct lumbar interbody fusion using auto and allograft; placement of lumbar interbody cage l3-l4, l4-l5 using auto and allograft; posterior spinal instrumentation l3-l4, l4-l5; posterior spinal fusion using auto and allograft l3-l4, l4-l5; lumbar laminectomy l4 ,l5; bilateral lumbar foraminotomy l4-l5.(b)(6) 2011: the patient was pre-operatively diagnosed with right retained stent and post-operatively right retained stent, distal end of stent had migrated proximally to the mid ureter.The patient underwent 1) flexible cystoscopy; right rigid ureteroscopy; stent extraction.(b)(6) 2011: the patient was diagnosed with: status post c5-c6 acdf on (b)(6) 2010; status post l4-l5 and l3-l4 dlif with posterior spinal instrumentation and fusion 2 years ago.Impressions: stable appearance status post l3-l4 and l4-l5; bilateral sacroiliitis.(b)(6) 2011: the patient presented for follow up visit at the hospital.(b)(6) 2011: the patient underwent x-rays of lumbar spine.Impressions: surgical changes with degenerative changes and facet arthropathy most prominent at l5-s1 with no subluxation on flexion-extension.(b)(6) 2011: the patient underwent mri scan.The impressions are: mild degenerative disc disease in the lower thoracic spine without significant mass effect; mild facet arthritis in the lower lumbar spine.Prior fusion at l3-l4 and l4-l5; l1-l2: desiccation narrowing and a mild bulge cause mild sac compression and mild bilateral foraminal stenosis; l2-l3: desiccation narrowing and a minimal bulge cause minimal sac compression and moderate bilateral foraminal stenosis; l3-4 and l4-l5: there is desiccation narrowing and mild bilateral foraminal stenosis.6) there is no significant focal disc contour abnormality or nerve root compression.(b)(6) 2011, the patient presented for follow up visit at the hospital.(b)(6) 2012: the patient presented for mri lumbar spine, without contrast.Impressions: stable mild posterior disc bulging l1-l2, non compressive; stable l2-l3 retrolisthesis with moderate foraminal stenosis.(b)(6) 2012: the patient was diagnosed with: status post c5-c6 anterior cervical diskectomy and fusion (b)(6) 2010; status post l4-l5 and l3-l4 dlif with posterior spinal instrumentation and fusion 2 years ago; l2-l3 lumbar disk herniation; right sacroiliac joint arthrosis; positive diagnostic and therapeutic effect to the left sacroiliac joint; positive diagnostic response to the sacroiliac joint but a negative therapeutic response; positive diagnostic response to the right l2-l3 foraminal injection (b)(6) 2012: the patient was pre-operatively diagnosed with: lumbar radiculopathy and underwent lumbar epidural; steroid injection under fluoroscopic guidance.(b)(6) 2012: the patient was pre-operatively diagnosed with: lumbar degenerative spondylolisthesis l2-l3 2) lumbar degenerative spinal stenosis l2-l3 3) lumbar foraminal stenosis, l2-l3 bilateral; adjacent level degeneration l2-l3 5) lumbar radiculopathy l2-l3 predominantly right side.The patient underwent following procedures: direct lateral interbody diskectomy; direct lateral interbody fusion using autograft and allograft; placement of olif cage; posterior spinal instrumentation; extension of fusion from l2 to l5 to prior fusion using autograft and allograft; lumbar laminectomy; bilateral foraminotomy 8) injection of the right si joint.(b)(6) 2012: the patient was pre-operatively diagnosed with sacroiliitis and underwent sacroiliac steroid injection under fluoroscopic guidance.(b)(6) 2012: the patient was pre-operatively diagnosed with: sacroiliac joint arthrosis, right side; sacroiliac joint instability, right side; severe sacroiliac joint pain, right side and underwent right sacroiliac joint fusion using sacroiliac bone.(b)(6) 2012: the patient underwent mri scan.The impressions are: stable mild posterior disc bulging l1-l2, non compressive; stable l2-l3 retrolisthesis with moderate foraminal stenosis; left foraminal crowding l4-l5,adjacent to interbody fusion device, with the area incompletely evaluated because of magnetic susceptibility artifact.(b)(6) 2012: the patient was pre-operatively diagnosed with lumbar degenerative disc disease and lumbar stenosis and underwent procedures: lumbar 2-3 direct lateral interbody fusion; posterior spinal fusion; extension of fusion; lumbar 2-3 foraminotomy and decompression; right sacral iliac injection; musculoskeletal exam (b)(6) 2012: the patient was diagnosed with status post l2-l3 direct lateral interbody fusion with posterior spinal instrumentation and fusion with extension of fusion.(b)(6) 2012: the patient presented for follow up visit at the hospital.(b)(6) 2012: the patient was pre-operatively diagnosed with: sacroiliac joint arthrosis, right side; sacroiliac joint instability, right side; severe sacroiliac joint pain, right side and underwent right sacroiliac joint fusion using sacroiliac bone.(b)(6) 2013: impression: the patient has had interval surgical fusion of the right si joint; no focal fracture or bony destructive process; postoperative changes of the lower lumbar spine; stable appearance of the left si joint noted.(b)(6) 2013: the patient underwent therapeutic fluoroscopically guided bilateral l5-s1 facet anesthetic/steroid injections.(b)(6) 2013: the patient underwent ct lumbar spine without contrast: spinal instrumented l2-l5 posterior decompression and fusion.No findings for post-op complication.Bony fusion across each of the interbody spacers; no central spinal stenosis.No findings for neural encroachment; mild inferior foraminal narrowing on the left at l4-l5 and on the right at l3-l4 without neural encroachment; transition l5 vertebra with associated left pseudoarticulation.(b)(6) 2013: the patient presented with a chief complaint of back pain.(b)(6) 2013: the patient presented with a chief complaint of back, right, left and lower pain.(b)(6) 2013: the patient underwent mri of lumbar spine without contrast.Impressions are as follows: surgical fusion l2 through l5 with well-positioned hardware and no evidence of residual or recurrent disc herniation or neural compression at the surgical levels; there is a stable mild disc bulge at l1-l2 not causing neural compression; no compression fracture.4) prominent facet arthropathy in lower lumbar spine.5) surgical fusion of right si joint.(b)(6).The patient presented for follow up visit at the hospital.(b)(6) 2014: the patient underwent radiofrequency ablation lumbar medial branches under fluoro.(b)(6) 2014, : the patient underwent transforaminal lumbar epidurial steroid injection under fl uoro.(b)(6) 2014: the patient underwent ct of pelvis sacrum without contrast due o right sided pain.Impression: visible joint space across the right sided si joint effusion.

• Brand Name: INFUSE BONE GRAFT
• Common Device Name: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 6696360
• Report Number: 1030489-2017-01704
• Device Sequence Number: 16363968
• Product Code: NEK
• UDI-Device Identifier: 00613994239518
• UDI-Public: 00613994239518
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P000058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7510050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 99