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

Catalog Number	7510100
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.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.
Event or Problem Description
It was reported that on: (b)(6) 2010: the patient was pre-operatively diagnosed with: herniated disk, l5-s1 right; degenerative disk disease l3-4, l4-5, l5-s1.The patient underwent following procedure: lumbar discectomy right l5-s1; posterior lumbar interbody fusion l3-4, l4-5, l5-s1; insertion of biomechanical device (peek cage l3-4, l4-5, l5-s1); posterior arthrodesis l3 to s1; pedicle screw instrumentation, l3 to s1; local bone graft harvest; bone marrow aspirate; fluoroscopy greater than one hour; microscope.As per op notes ¿ this was then packed with a combination of bone graft and bone graft material.Then a peek cage was inserted containing bone graft material with distraction of the disk space.Epidural space was then irrigated copiously.The exiting and traversing nerve roots were found to be supple and mobile and hemostasis achieved¿.Patient alleges unspecified injury due to the use of rhbmp-2.
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: 6228125
• Report Number: 1030489-2017-00047
• Device Sequence Number: 955313
• Product Code: NEK
• UDI-Device Identifier: 00613994239525
• UDI-Public: 00613994239525
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2016

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: 04/01/2011
• Device Catalogue Number: 7510100
• Device Lot Number: M110910AAF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2016
• Supplement Date Received by Manufacturer: 12/12/2016
• Initial Report FDA Received Date: 01/06/2017
• 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
• Patient Age: 46 YR