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 Post Operative Wound Infection (2446)

Event Date 08/29/2014

Event Type  Injury  

Event Description

It was reported in a publication that the authors reviewed data from the 2009 kid developed by the healthcare cost and utilization project, sponsored by the agency for healthcare research and quality.The authors identified 9538 discharge records associated with spinal fusion surgery in pediatric patients up to 20 years of age in 2009.Because the database is a weighted national sample, this represents an estimated 14 ,264 cases of spinal fusion surgery in the us.Nearly 11% of these cases involved intraoperative bmp use.1541 cases with bmp use vs 12723 cases without bmp use.Overall, rates of dvt, meningitis, wound infection, and wound dehiscence remained low (<(><<)> 2%).Patients with intraoperative bmp use had lower rates of blood transfusion.Post-op, 13 patients in the bmp cohort developed wound infection.

Manufacturer Narrative

Article citation: lam et al.Nationwide practice patterns in the use of recombinant human bone morphogenetic protein¿2 in pediatric spine surgery as a function of patient-, hospital-, and procedure-related factors.J neurosurg: pediatrics / august 29, 2014.(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: 4524244
• MDR Text Key: 5408383
• Report Number: 1030489-2015-00326
• 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: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• 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: 01/26/2015
• 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
• Patient Outcome(s): Required Intervention