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 Ossification (1428); Nerve Damage (1979); Neuropathy (1983); Pain (1994)

Event Type  Injury  

Event Description

It was reported that the patient underwent a l4-l5 and l5-s1 anterior total diskectomy and interbody fusion and l4-l5 and l5-s1 bilateral posterior spinal fusion in which rhbmp-2/acs was used.It was reported that imaging studies showed that the patient had developed uncontrolled bone growth and resulting nerve compression at or near the implant site.The patient developed chronic pain, radiculitis, emotional distress, and mental anguish.

Manufacturer Narrative

(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on: (b)(6) 2013: the patient was admitted.On (b)(6) 2013 the patient presented with the following preoperative diagnoses: l4-l5 and l5-s1 severe spondylosis with bilateral fo raminal stenosis; bilateral lumbar radiculopathy and axial back pain refractory to conservative management.The following operations were performed: l4-l5 and l5-s1 anterior total discectomy and interbody fusion using peek, bone morphogenic protein 2 and putty; bilateral l4 and l5 indirect spinal nerve root decompression; anterior arthrodesis from l4 to s1 using large frag screw and washer x2; bilateral l4, l5 and s1 posterior spinal fusion using pedicle screws, rods and autologous bone; use of and interpretation of intraoperative fluoroscopy; use of intraoperative neuromonitoring data.On (b)(6) 2013 the patient also presented with the following preoperative diagnoses: spondylosis, degenerative disk disease.The patient also underwent the following procedure: anterior exposure of l4-l5 and l5-s1 disk space.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4269531
• MDR Text Key: 5029272
• Report Number: 1030489-2014-04496
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

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: 10/24/2014
• Initial Date FDA Received: 11/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2016
• 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