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

Catalog Number	7510400
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 the patient underwent fusion surgery in which rhbmp-2/acs was implanted.On (b)(6) 2010: the patient was pre-operatively diagnosed with spinal reoperation.Spinal disc herniation.Spinal disc degeneration.Spinal stenosis.Spinal instability.Status post previous lumbar laminectomy l3 to s1 and underwent the following procedures: gill laminectomy l2-l3, l3-l4, l4-l5, l5-s1.Lumbar discectomy, l4-l5, l5-s1.Resection of epidural scar.Neurolysis of l5 nerve roots bilaterally.Code 22 reoperation.Use of intraoperative fluoroscopy.Fusion, posterolateral l2, l3, l4-l5, and s1 fusion, autograft and bmp.Fusion posterior lumbar interbody l4-l5 autograft.Fusion posterior lumbar interbody l5-s1 autograft, allograft, and bmp.Instrumentation machine tooled bone dowel, l4-l5 posterior lumbar interbody, machine tooled bone dowel l5-s1 posterior lumbar interbody.Screws l2, l3, l4-l5, and s1.Placement of epidural morphine.As per op-notes,¿ the locally obtained bone was mixed with bmp and placed posterolaterally for fusion at l2, l3, l4, l5 and s1.The interspace was distracted and via the posterior lumbar interbody route large volumes of autograft and bmp was placed into the vertebral space at l4-l5.¿ 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: 7277610
• Report Number: 1030489-2018-00244
• Device Sequence Number: 16642637
• Product Code: NEK
• UDI-Device Identifier: 00681490843805
• UDI-Public: 00681490843805
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P000058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

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: 07/01/2012
• Device Catalogue Number: 7510400
• Device Lot Number: M110806AAH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 02/16/2018
• 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