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) 2011: the patient presented with following pre-op diagnosis: l3 lateral recess spinal stenosis, secondary to ligamentum flavum hypertrophy, facet capsular hypertrophy, neuroforaminal narrowing secondary to disk space height collapse and bulging.L4 lateral recess spinal stenosis, secondary to ligamentum flavum hypertrophy, facet capsular hypertrophy, neuroforaminal narrowing secondary to disk space height collapse and bulging.L3-4 pseudarthrosis.History of l3-4 posterior decompression and instrumented posterolateral fusion in 2009.L3-4 unstable spondylolisthesis.Failure of posterior instrumentation.Lower extremity radiculitis.Mechanical back pain.She underwent the following procedures: l3-4 anterior discectomy with decompression of cauda equine and nerve roots.L3-4 vertebral interspace application of bone graft filled in a lordotic cage.L3-4 arthrodesis, retroperitoneal anterior interbody technique with allograft and bone morphogenic protein placed within the interbody device.Exploration of fusion.Continuous bilateral lower extremity emg monitoring.Navigation for spine surgery.As per operative notes, ¿peek cage chosen for implantation was filled with bone morphogenic protein, collagen sponges, and then impacted into place under fluoroscopic imaging and surgical navigation.Direct visual imaging from the lateral retroperitoneal approach as well as fluoroscopic imaging in the anterior-posterior and lateral planes confirmed excellent placement of the cage.¿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: 7428008
• Report Number: 1030489-2018-00546
• Device Sequence Number: 1949672
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

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: 06/01/2014
• Device Catalogue Number: 7510200
• Device Lot Number: M111063AAW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 04/13/2018
• 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