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

Catalog Number 7510400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that on: (b)(6) 2008: the patient was presented with laminectomy syndrome, spondylolisthesis at l3-4, severe l5-s1 stenosis, prior history of l4-5 laminectomy, right-sided radiculopathy.So he underwent bilateral lumbar laminectomy at l5 s1 with decompression of the exiting and traversing nerve roots.Re-do bilateral laminectomy at l4-5.Far lateral transpedicular decompression on the right at l3-4 of decompression of exiting nerve root.Anterior posterior spinal fusion from l3 through s1 with peek interbody cages, pedicle screw and rod instrumentation at 3 interspaces l3 through s1.Case done endoscopically under biplane fluoroscopy.As per op-notes ".A s1 fusion was done.Preparing the endplates for fusion a peek cage with bmp sponge was impacted across the midline and the remaining disk space was filled with dbm.A peek cage with bmp sponge was impacted across the 4-5 disk space and remaining disk space filled with dmb.The remaining facet joint was drilled out.Peek cage with bmp sponge was impacted across the midline.Additionally dmb was used to fill the disc space." on (b)(6) 2014: the patient was presented with spinal stenosis, degenerative disc disease so he underwent laminectomy at l2 and l3, posterolateral fusion l2-3 with onlay bone graft, autograft for spinal surgery morselized via the same incision.As per op notes ".The bones graft was morselized from the same incision.Decortication was performed at l2 and l3 and the bone graft was placed in an onlay fashion at l2-3 bilaterally to perform the posterolateral fusion at l2 3 with bone graft via the same incision." on an unknown date post-op patient alleged unspecified injuries due to use of rhbmp-2/acs.

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: 5665897
• MDR Text Key: 45470290
• Report Number: 1030489-2016-01459
• 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: 04/25/2016

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
• Device Expiration Date: 10/01/2010
• Device Catalogue Number: 7510400
• Device Lot Number: M110706AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/19/2016
• Supplement Dates Manufacturer Received: 04/25/2016
• Supplement Dates FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2008
• 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