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 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
It was reported that on: (b)(6) 2007: the patient presented with the following pre-op diagnosis: spondylolisthesis, l4-5.Spondylolisthesis, l5-s1.She underwent the following procedures: l4-5 laminectomy, medial facetectomy and foraminotomy.L5-s1 laminectomy, medial facetectomy and foraminotomy.L4 to the sacrum posterior instrumentation, segmental, with pedicle screws.L4 to the sacrum posterolateral fusion with local autograft and bmp.As per the operative notes, ¿she is brought to the operating room for l4 to the sacrum decompression and fusion with possible interbody graft.Patient understood that we would use bone morphogenic protein and local autograft rather than take bone graft from her hip.The wound was copiously irrigated with antibiotic solution.A 16-gauge catheter was then threaded cephalad through the residual l4 lamina and a combination of 3.5 cc duramorph and 3.5 cc of 0.25% marcaine were injected in the epidural space for postoperative analgesia.Tisseel fibrin glue was then used to achieve hemostasis in the epidural space and seal the epidural space from any errant bone morphogenic protein that might leak towards the canal.Cobb elevators were then u sed to retract the paraspinous muscles lateral to the screw heads and a combination of local autograft from the laminectomy and bmp soaked in compression resistant matrix was placed lateral to the screws and between the transverse process of l4, the transverse process of l5, and the sacral ala bilaterally.¿ no intra-operative complications were reported.Post-operatively, the patient alleged unspecified injury due to the use of rhbmp-2/acs.

• 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: 8008254
• Report Number: 1030489-2018-01409
• Device Sequence Number: 1395286
• 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: 2007
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2018

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: 11/30/2009
• Device Catalogue Number: 7510800
• Device Lot Number: M110608AAD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/26/2018
• 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