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 04/30/2014

Event Type  Injury  

Event Description

It was reported in a publication that a retrospective review of prospectively recorded data in a consecutive series of 155 patients was conducted.Patient had degenerative lumbar conditions and were treated at a single institution from 2008-2012 with a minimum follow-up of one year.97 patients underwent tlif with local bone graft without rhbmp-2/acs.58 patients underwent tlif with local bone graft and rhbmp-2/acs.Complications were identified in both groups.These were broadly categorized as increased post-op drainage (>800mls), infection, and new neurologic symptoms.There were 9 complications in 9 patients in the bmp group.Five other complications were deemed unrelated to bmp use (stroke, screw malposition, epidermal cyst arising beside incision site, atelectasis, cardiogenic pain) and were not included in the analysis.1 patient in the bmp group had a postoperative wound infection requiring formal surgical debridement.

Manufacturer Narrative

Article citation: liau et al.Complication rates in transforaminal lumbar interbody fusion using low-dose recombinant bone morphogenic protein-2 (rhbmp-2).Abstract of the international society for the advancement of spine surgery (isass) 2014, 30- apr to 02-may, miami usa.(b)(6).(b)(4).

• 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: 4802839
• MDR Text Key: 15387556
• Report Number: 1030489-2015-01082
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 05/28/2015
• 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