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

Catalog Number	7510400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neuropathy (1983); Pain (1994); Weakness (2145); Burning Sensation (2146); Tingling (2171); Numbness (2415)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) medical center, (b)(6): (b)(4).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) 2010: the patient presented with the following pre-op diagnosis: l3-4 and l4-5 disc protrusion with annular tears and underwent the following procedures: l3-4 and l4-5 anterior lumbar interbody fusion via direct lateral approach, endoscopically assisted.Placement of carbon fiber fusion cages at l3-4, l4-5.Placement of bone morphogenic protein(bmp).As per operative notes,¿ the annulotomy, discectomy ,endplate preparation was done, shaping and fitting of the disc space to a size 10 non-lordosed (parallel) 55 mm cage was done and placed at l3-4 that was prefilled with the bmp and was secured with absorbable 2-0 vicryl suture.Similarly, procedure was performed at l4-5.X-rays revealed quite good cage placement at both levels." no intra-operative complications were reported.Post-op, the patient complained of increasingly severe pain in his low back with radiculopathy, weakness, numbness, tingling and burning into his legs.It was reported that the patient experienced severe and unrelenting low back pain and swelling, numbness and tingling from his back down into his hips and legs, and burning in his calves, as well as difficulty in standing and walking.

• 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: 7521222
• Report Number: 1030489-2018-00714
• Device Sequence Number: 1224151
• Product Code: NEK
• UDI-Device Identifier: 00681490843805
• UDI-Public: 00681490843805
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 05/17/2018

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: 7510400
• Device Lot Number: M110908AAO
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/17/2018
• 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