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

Catalog Number	7510100
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.
Event or Problem Description
It was reported that on: (b)(6) 2011: the patient was pre-operatively diagnosed with l5-s1 degenerative disc disease with radiculopathy and underwent following procedure: l5-s1 laminectomy to decompress nerve root.L5-s1 interbody fusion with rhbmp-2/acs.L5-s1 interbody spacer local bone graft l5-s1 segmental pedicular fixation with pedicle screws emg nerve conduction studies during screw insertion, 4 levels two nerves tested.As per op-notes, ¿the facet joint at l5-s1 was identified an removed.Once the facet joint was removed, the epidural space was entered and a triangular working zone was identified.The disc space was entered using a series of sequential dilators going from 6mm up to 12 mm.The space was dilated nicely open and the intervertebral disc space removed completely.The wound was then irrigated.The bone chips that were harvested from the facet joint were taken and placed into the anterior portion of the interspace.An 11 mm spacer with a pledget of rhbmp-2 was then placed into the space and pounded into the anterior half of the intervertebral disc space.¿ patient tolerated the procedure with no complications.
Additional Manufacturer Narrative
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.

• 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: 6649410
• Report Number: 1030489-2017-01563
• Device Sequence Number: 19201979
• Product Code: NEK
• UDI-Device Identifier: 00613994239525
• UDI-Public: 00613994239525
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2011
• Device Catalogue Number: 7510100
• Device Lot Number: M111053AAH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 10/04/2017
• 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