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

Catalog Number	7510600
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 applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on: (b)(6) 2004: the patient presented with the following pre-op diagnosis: chronic lower back pain with degenerative disc disease.The patient underwent transperitoneal anterior exposure of lumbar spine and on-q pain reduction catheter placement.As per the operative notes,¿ the rest of the soft tissue structure at the l3-l4 was freed with dissector.The surgeon then subsequently performed the anterior lumbar interbody fusion at l3-l4 and l4-l5 and l5-s1.The surgeon subsequently performed the posterior lumbar interbody fusion with pedicle screw fixation, rhbmp-2/acs was used in the procedure.¿ no intra-operative complications were reported.

• 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: 7608855
• Report Number: 1030489-2018-00858
• Device Sequence Number: 14023836
• Product Code: NEK
• UDI-Device Identifier: 00681490843812
• UDI-Public: 00681490843812
• 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: 2004
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

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: 7510600
• Device Lot Number: M111003AE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/18/2018
• 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