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 No Information (3190)

Event Date 10/10/2014

Event Type  Injury  

Event Description

It was reported in a publication that the authors used the pearldiver technologies private payer database containing all records from united health-care from 2005 to 2011 to query all cases of pediatric spinal fusion with or without bmp use.A review of the literature was also performed to examine the complications associated with bmp use in pediatric spinal fusion a total of 4658 patients underwent spinal fusion.The majority underwent thoracolumbar fusion (93.13%).Bone morphogenetic protein was used in 1752 spinal fusions (37.61%).Of the 1752 cases in which spinal fusion involved bmp, 172 patients (9.8%) had a complication.Of the 2906 patients without bmp, 287 (9.9%) had a complication.This difference was not statistically significant.108 patients in the bmp cohort developed other complications.

Manufacturer Narrative

Article citation: rocque et al.Bone morphogenetic protein¿associated complications in pediatric spinal fusion in the early postoperative period: an analysis of 4658 patients and review of the literature.J neurosurg: pediatrics / october 10, 2014.Patients: 4424 patients aged between 10 and 19 years.Patients: 234 patients aged younger than 10 years.Patients: 3048 females, 1610 males.Implant date: 2005 to 2011.(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: 4260021
• MDR Text Key: 21837989
• Report Number: 1030489-2014-04428
• 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: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• 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: 10/20/2014
• 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