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

Catalog 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 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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
Event or Problem Description
It was reported that on (b)(6) 2008, patient presented with pre-op diagnosis, cervical radiculopathy and underwent following procedures: c5-6 and c6-7 anterior cervical diskectomies.Utilization of 2 separate biomechanical devices for arthrodesis between c5-6 and c6-7.Interbody devices, anatomical peek cages filled with rhbmp-2/acs.Anterior cervical instrumentation utilizing a anterior cervical plate with screws at c5, c6 and c7.Continuous neurophysiologic monitoring.Per op-notes, "the wound was then irrigated with copious amounts of antibiotic-impregnated saline, and a 6 mm trial was inserted in each disk space and noted to be of adequate size.A rasp was then passed into each disk space to prepare the endplates, and then 2 separate 6mm x 14mm anatomical peek cages were filled with one-quarter of rhbmp-2/acs.Each of these interbody devices was tapped into place under direct fluoroscopy, confirming adequate placement and good cervical lordosis.An appropriately sized plate was then place atop the vertebral bodies after shaving some of the remaining osteophytes from c5-6.This was secured in place with a temporary pin, and then a hand drill was used to drill 4 separate pilot holes, 2 each in the c5 and c7 vertebral bodies.Working in an alternating fashion, variable angle screws were placed in the c5 and c7 vertebral bodies.The c5 vertebral body would accommodate 3.5-mm x 13-mm screws, and 15-mm screws would be placed in the c7 vertebral body.After sequentially securing these screws down under direct lateral fluoroscopy, the screws were noted to pass below the locking rings on the plate.There was excellent screw purchase, after which 2 additional screws were placed in the c6 vertebral body after drilling pilot holes.These would be 3.5-mm x 13-mm screws.After these screws were passed below the locking ring, a final ap and lateral image was obtained, confirming excellent implant placement and good cervical lordosis.Final tightening at each screw was completed, and again the locking rings were noted to pass over each screw head at each insertion site.The wound was then irrigated with copious amounts of antibiotic-impregnated saline, and the platysma was then closed with interrupted and running 3-0 vicryl stitch." no patient complications were reported as a result of the event.Patient alleges unspecified injury due to the use of rhbmp-2.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.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: 6299100
• Report Number: 1030489-2017-00205
• Device Sequence Number: 537467
• Product Code: NEK
• UDI-Device Identifier: 00613994239518
• UDI-Public: 00613994239518
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P000058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2017

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: 12/01/2008
• Device Catalogue Number: 7510050
• Device Lot Number: M110715AAB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: 01/09/2017
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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