MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Device Problem Insufficient Information (3190)

Patient Problems Loss of Range of Motion (2032); Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

It was reported that the patient had significant physical and mental disabilities, since he was born with microcephaly and cerebral palsy.During the patient¿s visit, the doctor recommended the patient to undergo surgery which will allow him to sit independent of his wheelchair.The patient underwent a posterior spinal fusion from t2-sacrum, in which rhbmp-2/acs was used in a posterior approach.After the surgery, the patient suffered from fever for several days.When blood, urine, and fungal cultures were negative for any issues, it was noted in patient¿s discharge summary that it was probably the bmp causing the fever.Since the surgery, the patient has been suffering from increased seizure activity and utis.In addition, he has lost flexibility.His pain has also increased since his surgery.

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: 4939311
• MDR Text Key: 6255156
• Report Number: 1030489-2015-01635
• 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