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

Catalog Number 7510800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

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.

Event Description

It was reported that on (b)(6) 2012, the patient was preoperatively diagnosed with pseudarthrosis of spine, l5-s1, status post posterior lumbar interbody fusion and posterolateral fusion with optimesh allograft technique and underwent the following procedures: repair of l5-s1 pseudarthrosis by anterior technique with cage and rhbmp-2, interbody spacer with screws and rhbmp-2.Prior to surgery ct scan revealed to have nonunion at the l5-s1 anterior interbody level.As per the op notes, ¿dissection was then continued with the cobb periosteal elevator, mobilizing the disk contents off the end-plates from both the caudal l5 and cephalad s1.Complete nonunion without fusion was seen.The 14-millimeter appeared to be the best fit.This was a peek cage, 14 millimeters.Three-quarters of the bone morphogenic protein-2 was applied into the central cavity of the cage and the other quarter was applied to the left side of the disk space, having gone through the right side for the interbody approach.After impaction of the graft, the screws were inserted.An awl was used to make the screw hole, followed by application of the 5.5-millimeter screws at each site.After this, the anterior hood for the cage was applied.Note that all screws had been firmly secured.¿ the patient tolerated the procedure well without any intraoperative complications.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7047912
• MDR Text Key: 92587531
• Report Number: 1030489-2017-02376
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843829
• UDI-Public: 00681490843829
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/21/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2015
• Device Catalogue Number: 7510800
• Device Lot Number: M111108AAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/16/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other