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 09/24/2014

Event Type  Injury  

Event Description

It was reported that a retrospective chart and x-ray review was performed on cases between 2002 and 2009, in which rhbmp-2 was used in acute trauma or posttraumatic reconstruction.These cases were then compared with a matched cohort without the use of bone morphogenetic protein-2.Group 1 was comprised a total of 193 patients whose treatment included rhbmp-2 (155 reconstructive and 38 acute open fractures).Group 2 was comprised 181 patients treated without the use of rhbmp-2 (145 reconstructive and 36 acute open fractures).If there was any mention of ¿seroma,¿ ¿abscess,¿ ¿erythema,¿ ¿drainage,¿ or ¿dehiscence¿ in the postoperative physical examination of any inpatient progress note or outpatient clinic note, a postoperative wound complication was recorded.Any administration of antibiotics given outside the standard 24-hour postoperative course, or 48 hours for open fractures, was considered prolonged antibiotic use.Reoperation rates and culture results from debridement procedures for postoperative wound complications were also recorded.In the bmp cohort, there were 4 patients that required at least 1 reoperation for a wound complication with documented infection based on intraoperative cultures.

Manufacturer Narrative

Article citation: chan et al.Wound complications associated with bone morphogenetic protein-2 in orthopaedic trauma surgery.J orthop trauma.2014 oct;28(10):599-604.(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: 4194163
• MDR Text Key: 5098264
• Report Number: 1030489-2014-04100
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• 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: 09/24/2014
• 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