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

Device Problem Malposition of Device (2616)

Patient Problem Hematoma (1884)

Event Date 04/09/2015

Event Type  Injury  

Event Description

It was reported in a publication that 77 patients were enrolled in a prospective study.Use of bmp-2 was determined on an individual basis.Demographic and operative characteristics were recorded.Fusion rates were determined by a blinded reviewer and several functional outcomes were collected including visual analog pain scores (vas), oswestry disability index (odi), sciatica bothersome index (sbi), and short form---36 (sf---36) scores.Outcomes data was collected at each follow up visit.Of the 77 patients enrolled, 29 received bmp and 48 did not.Increased use of iliac crest autograft (41.7% vs 6.9%, p =.001) and blood loss (1035.2 vs 608.6 cc, p =.042) were noted in the control group.There were significant improvements in postoperative leg pain as measured by vas leg and sbi scores for the entire cohort without clinically significant differences between the bmp and control groups.Significant improvements were also found in vas back, odi, and sf-36 scores.Two reoperations occurred in each group for misplaced hardware, hematoma evacuation, and revision decompression.

Manufacturer Narrative

Article citation: sebastian et al.Prospective evaluation of radiculitis following bmp-2 use for interbody arthrodesis in spine surgery.8th annual lumbar spine research society (lsrs) meeting 2015, 09-10 april chicago, usa.Implanted date: may 2009 ¿ september 2013.(b)(6).(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: 4795614
• MDR Text Key: 5818258
• Report Number: 1030489-2015-01039
• 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

• 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
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/26/2015
• 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