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); Meningitis (2389); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.

Event Description

It was reported that: on (b)(6) 2010, the patient underwent direct lumbar interbody fusion with a side approach.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery and the patient has increased fear of cancer.On (b)(6) 2010, the patient underwent an axial surgery (stage 2 of the procedure) with instrumentation (second stage of the fusion procedure).A rod was placed at the base of the patient's spine.The patient complained of sciatic pain.On (b)(6) 2011, the patient underwent foraminotomy and decompression.The patient began projectile vomiting and had a substantial fever when he woke up in recovery.Allegedly, "after extensive tests, the patient was detected to have bacterial spinal meningitis.The patient could not even walk.After 73 days, the patient was released from the rehab center.The patient could then walk with the assistance of a walker and required help to get in and out of a vehicle.After (b)(6) 2011, the patient was diagnosed with normal pressure encephalitis on his brain.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6492543
• MDR Text Key: 72781993
• Report Number: 1030489-2017-00816
• 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: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: 03/21/2017
• Supplement Dates FDA Received: 10/02/2017
• 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