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 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.Information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with segmental instability with stenosis and facet arthropathy l4-5, l5-s1 and underwent the following procedures: anterior peritoneal approach l4-5 and l5-s1.Complete discectomy l4-5 and l5-s1.Anterior interbody fusion with bone morphogenic protein and cage, l5-s1.Spinal instrumentation with anterior cervical plate l4-5 and l5-s1.As per op-notes,¿ the complete disk was removed.The posterior longitudinal ligament was released.A complete diskectomy was performed.Removal of the entire disk was done and the end plates were fashioned out.A series of sizing devices were used.A 14-mm 10-degree medium sized cage was chosen and implanted with bone morphogenic protein within the substance of the cage.A 43-mm l5-s1 plate was chosen and implanted with 22-mm screws.All connections were checked and double checked with a torque device.Attention was then turned to the l4-5 level where annulus was incised in a 10 o'clock to 2 o'clock fashion and a series of elevators and curettes were used to elevate the disk from the vertebral body end plates and removed the complete disk.Posterior longitudinal ligament was released.The complete diskectomy was then completed and all end plates were freshened up to allow punctate bleeding bone.A series of sizing devices were chosen and a 14-mm 5-degree medium sized cage was implanted with bone morphogenic protein within the substance of the cage.The fit again seemed quite good.¿ 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: 7326408
• Report Number: 1030489-2018-00356
• Device Sequence Number: 109560
• Product Code: NEK
• UDI-Device Identifier: 00681490843812
• UDI-Public: 00681490843812
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

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: 03/01/2011
• Device Catalogue Number: 7510600
• Device Lot Number: M110709AAU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 03/09/2018
• 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