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

Catalog Number	7510800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on (b)(6) 2003: the patient presented with following pre-op diagnosis: pseudarthrosis lumbar spine, l4-l5, l5-s1.Lumbar degenerative instability, l3-l4.Failed posterior spinal instrumentation, pedicle screws in l4 and s1.Status posts multiple low back operations, including laminectomy and instrumented spinal fusion l4 to the sacrum, with non-segmental instrumentation (steffee plate and screws in l4 and 51).The patient underwent the following procedures: arthrodesis lumbar spine via retroperitoneal exposure, anterior body fusion l5-s1.Additional revel, arthrodesis lumbar spine, anterior lumbar interbody fusion l4-l5.Additional level, arthrodesis lumbar spine, anterior lumbar interbody fusion l3-l4.Insertion of a prosthetic device in the interbody space, peek cage l5-s1.Additional level, insertion of a prosthetic device in the interbody space, peek interbody cage at l4-l5.Additional level, insertion of a prosthetic device in the interbody space, peek cage in the interbody space at l3-l4.Insertion of bone morphogenic protein(bmp) in the interbody cages at l3-l4, l4- l5, and l5-s1.As per operative notes,¿ a 16-mm anterior height cage with an 8- degree lordotic angle was packed with bone morphogenic protein(bmp) on the collagen sponge.The cage was then inserted into the disc space at l3-4.Again the cages were placed under c-arm guidance, with good bony contact.The cages were tight in their disc spaces.Gelfoam was placed over the annulotomy sites.¿ no intra-operative complications were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7677011
• Report Number: 1030489-2018-00980
• Device Sequence Number: 1554507
• Product Code: NEK
• UDI-Device Identifier: 00681490843829
• UDI-Public: 00681490843829
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 7510800
• Device Lot Number: M0111001B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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