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	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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) 2016: the patient was pre-operatively diagnosed with status post fusion l3-s1 with pedicle screw instrumentation.Severe spinal stenosis, l2-l3 with fixed sagittal imbalance and underwent the following procedures: exploration of fusion and removal of hardware l3-s1.Posterior based osteotomy, l2-l3.Pedicle screw instrumentation, l1-s1.Posterolateral lumbar fusion, l1-l2, l2-l3, l3-l4, l4-l5, and l5-s1.Direct lateral interbody fusion through retroperitoneal approach with placement of anterior lumbar interbody cage, l2-l3 supplemented with bone morphogenic protein (bmp).As per operative notes,¿ the cage was placed from the anterior approach.It was tamped down slightly to move into a better position for correction of the deformity.This was done without complication.Rods were contoured appropriately.Appropriate in situ correction was used.Rods were contoured from l1-s1, screw testing was done, there were no complications.The transverse process and lamina were decorticated.Bone graft substitute and allograft bone was placed posterolaterally.A deep drain was placed.The fascia was closed.The skin was closed in layers.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 7401805
• Report Number: 1030489-2018-00519
• Device Sequence Number: 13734317
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 04/05/2018

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: 02/01/2018
• Device Catalogue Number: 7510600
• Device Lot Number: M111507AAD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/05/2018
• 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