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

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

Patient Problem Unspecified Infection (1930)

Event Date 03/01/2014

Event Type  Injury  

Event Description

It was reported that a retrospective chart and x-ray review was performed on cases performed between 2002 and 2009 at a single trauma center in which rhbmp-2 was used in acute trauma or post-traumatic reconstruction.These cases were then compared to a matched cohort without the use of bmp-2 (matched for age, type of case, anatomic site, and open injury) for statistical analysis.Group one was comprised of a total of 193 patients whose treatment included rhbmp-2 (155 reconstructive and 38 acute open fractures).Group two was comprised of 181 patients treated without the use of rhbmp-2 (145 reconstructive and 36 acute open fractures).For the acute trauma cases, all were open fractures where rhbmp-2 was applied after the final debridement and immediately prior to definitive wound closure during the initial hospitalization.Reconstructive cases were comprised either of diaphyseal nonunions or primary or revision post-traumatic foot <(>&<)> ankle fusions where rhbmp-2 was applied in an off-label fashion to enhance nonunion repair or arthrodesis, respectively.4 patients in the bmp group had post-op infection requiring revision.

Manufacturer Narrative

Citation: chan et al.Wound complications associated with bmp-2 in orthopaedic trauma surgery.Journal of orthopaedic trauma.2014.Doi: 10.1097/bot.0000000000000117.Average age 52 years.Range 16 - 90 years.Implant date: 2002-2009.(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.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.

• 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: 3781408
• MDR Text Key: 4377512
• Report Number: 1030489-2014-02362
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2014
• 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): Required Intervention
• Patient Age: 00052 YR