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

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2014

Event Type  Injury  

Event Description

It was reported by gupta et al in an article entitled ¿can low dose rhbmp-2 replace iliac crest bone graft in achieving successful fusion in adults with a long fusion to the sacrum?¿ (spine journal, suppl.1 14.11 (nov 1, 2014): s158) that a retrospective review of patients with minimum 5-level fusions treated with ldbmp or icbg was studied from two centers.One center used ldbmp and the other icbg.Radiographic analysis and chart review was performed.Minimum follow-up was 2 years.46 ldbmp and 43 icbg patients had adequate radiographic and clinical follow-up.The mean age was 63 years for both groups.The average follow-up was 25 months for ldbmp and 26 months for icbg.The total amount of rh-bmp-2 used in each patient was 1-3 large kits (12mg/kit).The average amount of rh-bmp-2 used was 18.52 mg (avg 1.78 mg/ level).There were 3 nonunions with icbg and 0 nonunions with ldbmp.The overall complication rate with ldbmp was 33% including 23% junctional breakdown, 6.52% cardiac, 0% neurologic, 6.52% respiratory, 4.34% gastrointestinal, 2.17% urological, with a total revision rate of 15.2 % percent.The efficacy of fusion, complication rate and reoperation rates were similar between the two groups.11 patients in the bmp cohort developed junctional breakdown post-op.

Manufacturer Narrative

Literature citation: gupta et al.Can low dose rhbmp-2 replace iliac crest bone graft in achieving successful fusion in adults with a long fusion to the sacrum? spine journal, suppl.1 14.11 (nov 1, 2014): s158.(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.

• 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: 4353379
• MDR Text Key: 5220350
• Report Number: 1030489-2014-04823
• 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
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 00063 YR