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); Injury (2348)

Event Type  Injury  

Event Description

It was reported that the patient underwent a posterior lumbar discectomy and decompressive laminectomy with fusion of l1-l5 using rhbmp-2/acs.Reportedly, sometime post-op, imaging studies revealed that the patient developed bony overgrowth at or near where the rhbmp-2/acs was implanted and nerve compression.The patient has experienced chronic pain and radiculitis.

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

(b)(4).

Event Description

It was reported that on: (b)(6) 2005: per operative notes ".The patient autologous bone and a 12 x 22 mm interbody spacer packed with bone and bmp sponge was carefully placed in through the tlif approach to the midline creating the anterior fusion via the tlif approach.Through that same incision, the patient autologous bone and bmp sponges were placed on the remaining laterals and central and transverse process completing a posterior fusion with 360 fusion.After discectomy was performed in the anterior and posterior fusion had been performed, mesial facetectomy was performed.6.5 x40 mm screw was screwed in at s1 and a 6.5 x 56 mm screw was screwed in the l5.Then using the rod holder, a 45 mm rod was threaded percutaneously through the skin into the heads of the screws and locked down with the tight end devices under compression, creating a posterior instrumentation.Patient tolerated the procedure well.Complication : none.".

• 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: 4270620
• MDR Text Key: 5032761
• Report Number: 1030489-2014-04514
• 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