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 Problems Ossification (1428); Neuropathy (1983); Weakness (2145); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted 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.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) 2006: patient presented with following pre-op diagnoses: degenerative/ mechanical discogenic low back pain secondary to de generative disk disease at l4-5.Far lateral foraminal disk herniation at l4-5.For which, patient underwent following procedures: hemilaminectomy at l4-5 on the right with complete facetectomy.Lysis of dense perineural adhesions of the l5 root on the right side.Removal of far lateral foraminal disk fragment and complete removal of the l4-5 disk.Transforaminal lumbar interbody fusion using a 10 mm x 28 mm cage packed with bone morphogenic protein and autogenous bone harvested locally.Pedicle screw fixation using percutaneous system consisting of two 6.5 x 45 mm screws and a 40 mm precurved titanium rod.Per op notes, a 10 mm x 28 mm cage was tapped into position and countersunk.Ahead of the cage, surgeon placed several sponges of bone morphogenic protein (bmp).The cage was itself was also packed with bone morphogenic protein (bmp).Ap and cross table lateral films revealed the cage to be in excellent position.Patient tolerated the procedure well with no complications reported.On (b)(6) 2013: patient presented with following pre-op diagnoses: post-laminectomy syndrome with severe right lower extremity radic ulopathy and weakness secondarily to hyperostosis and its overgrowth secondary to a transforaminal lumbar interbody fusion with bone morphogenic protein, right worse than left.For which, patient underwent following procedures: posterior lumbar exploration of s pinal arthrodesis with: two-column posterior osteotomy at l4-l5 for removal of severe bony overgrowth out of the disc space with posterior and medial column taken down with: transfacet decompression/transpedicular decompression at l4-l5 to remove excess bone and decompress the spinal stenosis and radiculopathy source with: duraplasty technique for the exiting l4 and traversing l5 roots on the right side with: identification of the complete absence of dura and open and direct repair of dural deficiency utilizing a dural graft from the fascia from the erector spine musculature to recreate dura on the right side of the epidural space.Per op notes, patient was operated on with a transforaminal lumbar interbody fusion in the right side utilizing a cage and bone morphogenic protein.Unfortunately, the patient had significant bony growth posteriorly, in the trajectory that was used to bring the cage with the bmp into disc space, initial severe radiculitis, and subsequently so much bony overgrowth, that the entire l4 foraminal and lateral recess of l5 was completely blocked by bone.Patient tolerated the procedure well with no complications reported.

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: 5649704
• MDR Text Key: 44998385
• Report Number: 1030489-2016-01369
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

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 Catalogue Number: 7510400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: 04/18/2016
• Supplement Dates FDA Received: 09/21/2017
• 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): Required Intervention
• Patient Age: 49 YR