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 Dysphagia/ Odynophagia (1815); Pain (1994); Loss of Range of Motion (2032); Numbness (2415)

Event Type  Injury  

Event Description

It was reported that the patient was suffering for lower back pain and difficulty walking.The patient had received injections and nerve blocks.On (b)(6) 2005, the patient underwent a laminectomy, tlif, posterior instrumentation, and posterior facet and intertransverse fusion at l4-l5.The patient was implanted with rhbmp-2/acs.Post-op,the patient lost flexibility and developed pain in left groin, which radiated down to left leg.On (b)(6) 2006, the patient underwent decompression, a posterior instrumental fusion, and a tlif at l2-l4.The patient was implanted with rhbmp-2/acs.The patient undergo another surgery in order to help with pain.The patient operated on cervical spine.The patient was implanted with rhbmp-2/acs.The patient began having difficulty in swallowing and coughing, experienced dizziness when turned the head, and had numbness down both of harms.Also the patient began having limited flexibility in neck.It was reported that in late (b)(6) 2009, the patient continued to experience pain and stiffness in back and neck, dizziness, arm-numbness, and had difficulty in swallowing.

Manufacturer Narrative

(b)(6).(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: 4943817
• MDR Text Key: 6258399
• Report Number: 1030489-2015-01683
• 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

• Date FDA Received: 07/27/2015
• 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?: No
• Date Manufacturer Received: 07/06/2015
• 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