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); Pain (1994)

Event Type  Injury  

Event Description

It was reported that the patient underwent spinal fusion surgery at l4 - l5 using rhbmp-2/acs with tlif surgical approach.Reportedly, sometime post-op, the patient developed a disc-osteophyte complex and deterioration of the l4-5 disc interspace.The patient continued to experience severe and unrelenting back pain.

Manufacturer Narrative

(b)(4).Neither the device nor applicable imaging study films or patient medical records were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted/used during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2007, the patient was preoperatively diagnosed with: low back pain; isthmic spondylolisthesis, l4-5; ruptured disc, l4-5; lumbar stenosis, l4-5.The patient underwent following procedure: l4 gill procedure with decompression of l4 nerve roots bilateral; repair dural leak, l4 right; l4-5 instrumentation, left; right l4-5 transforminal lumbar interbody fusion; two screws, one hour; bone morphogenic protein, small.As per op notes, ¿lateral x ray revealed a very satisfactory position.Bone morphogenic protein, small batch was used and mixed up with one sponge wrapped in some of the bone from the posterior elements placed anteriorly, and then one sponge cut in two pieces and place in the peek cages before it was seated into the l4-5 interspace.This was the fusion itself.¿.

• 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: 4271359
• MDR Text Key: 5298371
• Report Number: 1030489-2014-04528
• 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: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• 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: 02/13/2017
• 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