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 Distress (2329); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

On an unknown date in 2005 it was reported that the patient presented with scoliosis.The doctor recommended surgery to straighten her spine.On an unknown date, the patient underwent spinal fusion surgery in which rhbmp-2/acs was used.Post-operatively, the patient developed a severe infection in the incision site and had to be hospitalized for this infection.On an unknown date in (b)(6) 2009, the patient underwent surgery to clean out the infection caused by the surgery.On an unknown date in (b)(6) 2009, the patient underwent a revision surgery on to fix the rods placed in her first surgery.Patient still had increasing pain and continued to have problems with the screws placed in her back.In (b)(6) 2012, doctor performed yet another surgery on the patient, while she was a minor.Immediately following this surgery, patient could not move her left foot.Doctor told patient she had a sprained ankle but an emergency nurse informed patient that she had ¿foot drop¿ as a result of the surgery.Patient was unable to put any weight on her left foot for a period following spinal surgery.As a result of the constant surgeries during her childhood, the patient suffered constant pain and discomfort.Patient had undergone constant mental anguish and distress as a result of the many surgeries.This anxiety and stress continues to this day.Patient now lives with chronic pain.

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: 4939702
• MDR Text Key: 21187495
• Report Number: 1030489-2015-01646
• 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: 07/24/2015
• 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; Required Intervention