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

Catalog Number	7510200
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 on: (b)(6) 2008: the patient presented with following pre-op diagnosis: cervical pseudarthrosis at c5-6 and possibly c4-5.Also, foraminal narrowing bilaterally, worse on the right to the left at c5-6.Patient underwent following procedures: (1) posterior spinal fusion c4-c5, c5-c6.(2) posterior spinal instrumentation, segmental, at 4-5, c5-c6.(3) autologous local bone grafting augmented with rhbmp2 and vitoss bone graft substitute.(4) posterior cervical bilateral c5, c6 laminotomies, foraminotomies and medial facetectomies.As per operative notes,¿ the posterior bony elements were decorticated, and the autologous local bone was used for fusion.The bleeding from the bone was used to soak the vitoss bone graft substitute.Then, rhbmp2 sponge was placed at the area of the posterior elements in the interspinous space, interlaminar space, and also the facet joints to enhance facet fusion.Then, bone graft substitute was added on top of the autologous bone and rhbmp2.¿ reportedly, the patient was diagnosed with the following post-operatively: cervical spondylosis and stenosis bilaterally in the foramen, worse on the right than the left at cs-6 and a solid fusion at c4-5 and a non-union at c5-6 or pseudarthrosis.No intra-operative complications were reported.

• 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: 7641147
• Report Number: 1030489-2018-00916
• Device Sequence Number: 1899593
• Product Code: NEK
• UDI-Device Identifier: 00681490843782
• UDI-Public: 00681490843782
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: 11/01/2010
• Device Catalogue Number: 7510200
• Device Lot Number: M110705AAA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 06/27/2018
• 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