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 04/30/2014

Event Type  Injury  

Event Description

It was reported in a publication that 52 patients undergoing a single-level unilateral mis tlif were evenly randomized into two coho rts; actifuse with 5cc of bone marrow aspirate (n=26) and rhbmp-2/acs (n=26).Ct analysis was performed at 6 months and 1 year post-operatively.At 1 year follow up, 65% of the actifuse cohort and 92% of the rhbmp2 cohort demonstrated a radiographic arthrodesis.A greater re-operation rate was noted in the actifuse cohort (35%) compared to the bmp2 cohort (7.7%).One patient with bmp2 also experienced symptomatic neuroforaminal bone growth.Two patients in the bmp2 cohort underwent re-operation.

Manufacturer Narrative

Article citation: nandyala et al.A prospective, randomized, controlled trial of silicate substituted calcium phosphate versus rhbmp-2 in a minimally invasive transforaminal lumbar interbody fusion.Abstract of the international society for the advancement of spine surgery (isass) 2014, 30-apr to 02-may, miami usa.(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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4802843
• MDR Text Key: 5830419
• Report Number: 1030489-2015-01080
• 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: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• 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: 04/28/2015
• 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