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

Catalog Number UNKNOWN

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

Patient Problem No Code Available (3191)

Event Date 09/10/2014

Event Type  Injury  

Event Description

It was reported by annis et al in a poster presentation (the fate of l5-s1 with low dose bmp-2 and pelvic fixation in adult deformity surgery.Final program of the (b)(4) meeting <(>&<)> course of the scoliosis research society (srs), 10- to (b)(6) 2014) that a retrospective review of 61 consecutive patients with minimum 2-year follow-up at a single institution was performed.All patients were required to have a posterior approach only, = 5 levels fused including l5-s1, use of pelvic fixation, and no prior l5-s1 procedures.The patients were divided in 2 groups for comparison based on the use of an interbody cage/fusion at the l5-s1 level.Radiographic union was assessed by 3 independent reviewers using bridwell¿s criteria.Revision rates and implant related complications were also reported.The fusion rate at l5-s1 was 95% (58/61) with no difference between the 2 groups (94.3% vs 96.2%, p=0.6).There were no significant differences in the radiographic parameters or deformity correction between the groups.The mean amount of bmp-2 inserted in the disc space in the interbody group was 2.5mg (0-8).In both groups a mean of 3.5mg (2-4) of bmp-2 was used posterolaterally, along with allograft and local autograft.The overall revision rate for l5-s1 nonunion was 1.6%.The use of low dose of bmp-2 at the l5-s1 level in combination with sacro-pelvic fixation achieved satisfactory fusion rates in adult deformity surgery.No additional benefit was encountered by adding an interbody cage.Three (3) patients developed non-union in this cohort.One (1) case required revision.

Manufacturer Narrative

Literature citation: annis et al.The fate of l5-s1 with low dose bmp-2 and pelvic fixation in adult deformity surgery.(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.

Manufacturer Narrative

Annis et al.The fate of l5-s1 with low dose bmp-2 and pelvic fixation in adult deformity surgery.Final program of the 49th annual meeting <(>&<)> course of the scoliosis research society (srs), 10- to 13-sept- 2014.Annis et al.The fate of l5-s1 with low dose bmp-2 and pelvic fixation in adult deformity surgery.Spine journal, suppl.1 14.11 (nov 1, 2014): s59.Annis et al.The fate of l5¿s1 with low dose bmp-2 and pelvic fixation in adult deformity surgery.Abstracts of global spine congress 2015, 20-23 may, buenos aires, argentina.(b)(4).

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4264892
• MDR Text Key: 5028089
• Report Number: 1030489-2014-04468
• Device Sequence Number: 1
• Product Code: NEK
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2015

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 11/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: INTERBODY CAGE
• Patient Outcome(s): Required Intervention