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	Injury (2348)
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
The patient was pre-operatively diagnosed with l4-l5 pseudoarthrosis with retained hardware, degenerative disc disease, segmental lumbar instability and spinal stenosis and underwent the following procedures: l4-l5 fusion exploration.L4-5 removal posterior segmental instrumentation.L4 revision laminectomy with decompression of cauda equina and spinal nerve roots.L5 laminectomy with decompression of cauda equina and spinal nerve roots.L4-l5 revision posterior spinal fusion.L4-l5 segmental instrumentation with pedicle screws.Use of local bone graft, cancellous allograft, and bmp.Insertion of indwelling opioid catheter for postop analgesia.Use of operating microscope.L4-l5 anterior lumbar diskectomy and interbody fusion.L4-l5 anterior lumbar machine allograft.L4-5 anterior segmental instrumentation.As per op-notes,¿ the level was confirmed using a lateral image with the spinal needle in place.The l4- l5 annulotomies carried out and a complete diskectomy and decompression from the anterior aspect of the disk space was performed.The peek interbody device was removed without difficulty.The patient had bmp used in the last surgery and there was some inadvertent extravasation of the disk space and this ectopic bone was removed through the anterior approach.The end plates were prepared as we proceed.A 13mm corticocancellous allograft was selected and a small central canal created.A half strip of bmp/acs was used to fill the space.A 41 mm lumbar plate from the synthes integra set was used and the lateral c-arm image reveals the appropriate length and it was then secured to the l4 and l5 bodies with four 6.5 x 20-mm corticocancellous locking screws.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 7662322
• Report Number: 1030489-2018-00961
• Device Sequence Number: 14082228
• Product Code: NEK
• UDI-Device Identifier: 00613994239518
• UDI-Public: 00613994239518
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 07/04/2018

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 Expiration Date: 09/01/2012
• Device Catalogue Number: 7510050
• Device Lot Number: M111105AAJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 07/04/2018
• 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