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); Dysphasia (2195); Coma (2417); Neck Pain (2433); Choking (2464); Ambulation Difficulties (2544); Weight Changes (2607)

Event Type  Injury  

Event Description

It was reported that the patient sought treatment with her surgeon in (b)(6) 2010.The patient was informed by her surgeon that she had two bulging discs and a neck fracture which necessitated surgery.On (b)(6) 2010 the surgeon performed cervical spine surgery in which rhbmp-2/acs was used.Following surgery, the patient's voice was very deep and scratchy.On (b)(6) 2010 the patient was sent to another doctor for one week of rehabilitation.The patient was in extreme pain and could not walk on her own without the assistance of cane or walker.On (b)(6) 2010 the patient had a post-operative visit with her original surgeon and she expressed pain and discomfort.Over the next several months, the patient was in constant pain.She was losing her ability to speak and even sought speech therapy treatment which was unsuccessful.On (b)(6) 2011, the patient, still in pain and having trouble getting around, went to her surgeon and received a steroid shot.In (b)(6) 2011, the patient was sent for additional rehabilitation.Over the next several months, the patient continued a cycle of hospital visits and visits in rehabilitation.Throughout this time, the patient lost her ability to speak and could not eat without choking.She lost a great deal of weight, going from (b)(6).She had to be lifted from a bed or chair to be wheeled around.In (b)(6) 2011, the patient was admitted to a hospital, where she continued to be in extreme pain, unable to eat, walk, or talk.She was able to write notes and point at things.Her pain was in her neck and all down her back.On (b)(6) 2011, the patient was admitted for dehydration and subsequently fell into coma.Patient died on (b)(6) 2011.

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: 4975781
• MDR Text Key: 21465525
• Report Number: 1030489-2015-01948
• 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: 08/05/2015
• 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