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 Problems Pain (1994); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

It was reported that in (b)(6) 2007 the patient injured his neck during wrestling match.The patient continued to suffer from intermittent pain for approx.A year and a half after the injury.On (b)(6) 2009, the patient underwent x-rays and mri of cervical spine.The results showed that the patient had slight straightening of the normal spine curvature, but that the spine was otherwise unremarkable.On (b)(6) 2009, the patient was told that he had a tear in the area around his c5-c6 vertebrae.The patient underwent epidural injections for pain relief.On (b)(6) 2009, the patient underwent cervical spinal fusion from c5-c6.The patient was implanted with rhbmp-2/acs.Post-op, the patient continued to suffer from incredible pain that did not diminish after the surgery.The patient was often unable to sleep, stand, or sit due to the extreme pain that he lives with every day.

Manufacturer Narrative

(b)(4).Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

• 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: 4961682
• MDR Text Key: 6036387
• Report Number: 1030489-2015-01869
• 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: 07/06/2015

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: 07/06/2015
• Initial Date FDA Received: 08/03/2015
• 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