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

Device Problem Insufficient Information (3190)

Patient Problem Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

It was reported that on (b)(6) 2008 the patient presented with preoperative diagnosis of l5-s1 pars defect.The patient underwent anterior exposure for anterior lumbar interbody fusion (l5, s1).Per-op notes: a 14mm graft had a good fit.The real graft was then impacted with a packet of medium bmp.A plate was placed anteriorly with two screws in 5 and 2 screws in s1.Final radiograph showed good position of the graft as well as the hardware.(b)(6) 2008 the patient presented with preoperative diagnosis of abdominal wound infection status post anterior lumbar inner body fusion, l5/s1.The patient underwent the following procedure: irrigation and debridement of abdominal wound, application of wound vac with a black sponge 125 mmhg of pressure.(b)(6) 2009 the patient presented with preoperative diagnosis of right hip stage iv avascular necrosis.The patient underwent right hip arthroplasty.(b)(6) 2010 the patient presented with preoperative diagnosis of avascular necrosis, left femoral head.The patient underwent left total hip arthroplasty.

• 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: 5294339
• MDR Text Key: 33428290
• Report Number: 1030489-2015-03423
• 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: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/16/2015

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?: No
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/14/2015
• 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): Other