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); Headache (1880); Swelling (2091); Numbness (2415); Neck Pain (2433)

Event Type  Injury  

Event Description

It was reported that the patient underwent ¿medically unnecessary, experimental¿ spine surgeries where cervical and thoracic rods, screws, cages and rhbmp-2/acs were implanted.The patient has sustained injury within the past four years.The patient has allegedly undergone related follow up care, physical therapy, prescriptions, injections, and image studies.It was reported that the patient underwent spinal fusion surgery from a c5-7 to t1 using rhbmp-2/acs.The patient underwent a cervical spinal fusion surgery, installing hardware and fusing c3-c4.Immediately following the surgery, the patient began suffering extreme headaches, neck pain, bilateral arm and leg pain, neck swelling, restricted breathing, being out of breath, and paralysis and numbness in both hands and legs.The patient complained that since the surgery, the pain became so extreme she could no longer bear it.On (b)(6) 2010, the patient underwent surgery where hardware and rhbmp-2/acs were implanted at t12-l1 due to bulging disc (as per surgeon).After these surgeries, the patient suffered extreme headaches, neck pain, bilateral arm and leg pain, neck swelling, restricted breathing, being out of breath, and paralysis and numbness in both hands and legs.The patient was partially paralyzed, immobile, and in constant pain.She had to use opioids to control her pain.

Manufacturer Narrative

(b)(6).(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.

Manufacturer Narrative

(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: 4916449
• MDR Text Key: 6025644
• Report Number: 1030489-2015-01472
• 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,Followup
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• 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; Disability