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

Catalog Number	7510600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on (b)(6) 2014, the patient underwent an anterior lumbar interbody fusion and posterolateral fusion surgery, and a posterior thoracolumbar fusion surgery on the lumbar region of her spine from vertebrae l1 to s1.Reportedly, patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed outside a cage, i.E., in the posterolateral region.Allegedly, the patient's post-operative period was marked by ¿a period of improvement followed by increasing pain in her low back and buttocks¿.It was reported that the patient presented with the following pre-op diagnosis: recalcitrant lumbago.Multilevel segmental lumbar spinal stenosis with foraminal stenosis.Degenerative lumbar disk disease.Degenerative spondylolisthesis.Degenerative scoliosis.The patient underwent the following procedures: anterior lumbar interbody fusion via left-sided retroperitoneal approach, l4-l5, l5-s1.Placement of intradiscal spacer, l4-l5 and ls-s1.Anterior spinal instrumentation with titanium vertebral retention screws l4 and s1.Use of bmp.Local bone grafting.As per operative notes, ¿ the spacer was filled with bmp, tamped into position with excellent interpositional fit and 25 mm titanium vertebral retention screws were inserted in the body of s1.The identical diskectomy was then performed and a 13 run tall, 12-degree lordotic spacer was filled with bmp, tamped into position with good interpositional fit and 25 mm retention screws were inserted into l4 along with the locking mechanism.¿ 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: 7618677
• Report Number: 1030489-2018-00872
• Device Sequence Number: 13808421
• Product Code: NEK
• UDI-Device Identifier: 00681490843812
• UDI-Public: 00681490843812
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 06/20/2018

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: 03/01/2016
• Device Catalogue Number: 7510600
• Device Lot Number: M111206AAY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/20/2018
• 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