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 applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient presented with the following pre-op diagnosis: neck pain and right upper extremity pain due to spondylosis at c5-c6.The patient underwent the following procedures: anterior cervical discectomy and fusion at c5-c6 with partial corpectomy with the use of 10mm cage and small amount of rhbmp-2/acs and 25mm plate and four 15mm screws with intraoperative single-strand conformation polymorphism monitoring on microscope and fluoroscopy.As per operative notes, ¿at this point, the wound was irrigated with antibiotic solution and disk space was measured and because of the osteophyte the surgeon had to do a partial corpectomy, a 10mm cage with small amount of rhbmp-2/acs was placed in and checked with fluoroscopy and koshers and there was no movement present and it was in perfect position.¿ no intra-operative complications were reported.On (b)(6) 2009 the patient was discharged from the facility.

• 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: 7608488
• Report Number: 1030489-2018-00857
• Device Sequence Number: 1422600
• 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
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 06/17/2018

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: 08/01/2011
• Device Catalogue Number: 7510200
• Device Lot Number: M110804AAK
• 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: 06/17/2018
• 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