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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient presented with the following pre-op diagnosis: severe degenerative spondylolisthesis l4-5 with foraminal stenosis bilaterally at l4-5 and sciatic pain left sides, degenerative spondylolisthesis, sciatic pain, degenerative disk disease.She underwent the following procedures: posterior lumbar fusion at l4-5 and posterior lumbar interbody fusion at l4-5, decompressive laminotomy and foraminotomy bilaterally, autologous bone graft harvesting, non segmental instrumentation l4-5 with pedicle screw fixation., insertion of biomechanical device, posterior lumbar interbody fusion cage at l4-5 from the left side,use of microscope for the decompressive procedure, platelet tissue graft material for fusion and closure.As per the operative notes: sizing was carried out and an 11 mm high cage was decided upon.X-ray with the 12-gauge in place did show some slightly over distraction on the left side.The 11 mm posterior lumbar interbody fusion cage was obtained.Bone morphogenic protein was obtained and the cage was packed with bone morphogenic protein.Decortication of the endplates was carried out using a bur bilaterally and the autologous bone which was mixed with the bone gel and platelet gel, was packed in, in a piecemeal fashion, also utilizing some infuse bone morphogenic protein.Attention was turned to left side again and decortication and lateral bone graft fusing was carried out using bone bank bone and platelet gel along with the remainder of autologous bone graft.

• 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: 7976413
• Report Number: 1030489-2018-01373
• Device Sequence Number: 1774382
• Product Code: NEK
• UDI-Device Identifier: 00681490843805
• UDI-Public: 00681490843805
• 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: 2007
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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: 02/01/2010
• Device Catalogue Number: 7510400
• Device Lot Number: M110701AAC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/17/2018
• 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