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

Model Number	7510050
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 manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that on: (b)(6) 2012: patient presented with following pre-op diagnosis: status post anterior cervical discectomy and fusion c5-6, c6-7.2.C5-6, c6-7 painful pseudoarthrosis.Painful retained hardware in c5-6, c6-c7.Patient underwent following procedures: revision of c5-6 anterior cervical discectomy and fusion with removal of intervertebral body fusion device.Revision of c6-7 anterior cervical discectomy and fusion with removal anterior cervical intervertebral body fusion device.Placement of c5-6 anterior cervical intervertebral body fusion device rhbmp-2/acs.Placement of c6-7 allograft anterior cervical intervertebral body fusion device with rhbmp-2/acs.Placement of c5-c7 anterior cervical plate which was re-implantation of anterior hardware.Per operative -notes: ¿¿appropriate size implant was obtained, packed centrally with rhbmp-2/acs soaked in collagen sponge.Implant was then tamped in position.Good endplate contact, good foraminal distraction.The caspar distractor was released and removed.Appropriate size anterior cervical plate was obtained, was affixed to the anterior cervical spine.A 15 mm long screws at each level two at c5, two at c6, and two at c7, variable angle screws were used at c5 and c6, fixed angled c7.Screw locking mechanism was secured each level.¿¿ patient tolerated the procedure well.Post operatively patient alleged unspecified injury due to use of rhbmp-2/acs.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6528798
• Report Number: 1030489-2017-01018
• Device Sequence Number: 1458011
• Product Code: NEK
• UDI-Device Identifier: 00613994239518
• UDI-Public: 00613994239518
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2017

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: 09/01/2012
• Device Model Number: 7510050
• Device Catalogue Number: 7510050
• Device Lot Number: M111105AAJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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