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 Problem Osteolysis (2377)

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.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.

Event Description

It was reported that on (b)(6) 2012 the patient underwent: posterior lumbar approach for exploration of fusion, redo laminectomy l5-s1, s1-s2 with decompression of the thecal sac, l5, s1, s2 diskectomy interbody fusion using rhbmp-2/acs and allograft synthes bone sponge, implantation of biomechanical device, which was at l5-s1 on the left side, a spine wave cage expanded to 10 mm and s1 , s2 two spine wave cages expanded on the left side to 10 mm, on the right side 9 mm.Removal of previous instrumentation on the right side at s1, nonsegmental pedicle screw instrumentation s2 on both sides using 7 mm diameter pedicle screws under radiographic guidance, posterolateral fusion l5, s1, s2 using actifuse material mixed with autograft bone from the laminectomy and vancomycin, use of intraoperative neurophysiological monitoring throughout the procedure.This was all done under the microscope for microsurgical techniques.Preoperative diagnosis: post-laminectomy syndrome l5-s1 with loosening of mechanical failure of pedicle screws with recurrent pain syndrome.The patient has segment disc herniation at s1-s2 with compression of the thecal sac.Per-op notes: "bilateral rods were removed and the right-sided l5 pedicle screws were clearly loose.The l4 pedicle screws on the left side and l5 pedicle screws were strong and in good position.Therefore, the decision was made to keep those screws in place.We then started out by performing a redo laminectomy at l5-s1 with decompression of the thecal sac.The left sided facet joint was removed and the exiting l5 nerve root was identified.A discectomy was performed here and the end plates were prepared for the fusion.A small sponge of bmp was inserted anteriorly, followed by an allograft bone sponge.We then placed a spine wave cage and expanded it to 10 mm without any problems and with good radiographic control.We then performed a laminectomy at s1-s2 and decompressed the thecal sac.We incised the disk space.This was, by the way, all done under the microscope for microsurgical techniques.The s1-s2 disk was incised and the disk space was prepared for the fusion using curettes and rongeurs and 2 small sponges of bmp were placed anteriorly followed by 2 small sponges of allograft material.We placed 2 spaces, 1 on the right side and 1 on the left side with good radiographic results.The space on the left side was expanded to 10 mm, the 1 on the right side to 9 mm.There was no csf leak.The monitoring remained stable." (b)(6) 2014 the patient underwent ct scan of the lumbar spine.Impression: spinal segmentation anomaly with six lumbar type verte brae.The fusion levels were termed l5-s1-s2 and is s1 is considered lumbarized, in keeping the prior convention.Posterior decompression and spinal fusion from l5-s2 with osteolysis involving the bilateral s2 screws, right greater than left, similar to prior.The l5-s1 level demonstrates some evidence of bony fusion.There is persistent osteolysis surrounding the s1-s2 interbody spacer with vaccum phenomenon, compatible with motion at this level.Suggestion of increased mild l4-5 anterolisthesis measuring approximately 4mm (sagittal reconstruction ).Bilateral l4-5 facet arthrosis with degenerative gas in the facet joints.

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: 5677811
• MDR Text Key: 45853548
• Report Number: 1030489-2016-01506
• 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: 05/02/2016

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: 05/02/2016
• Initial Date FDA Received: 05/25/2016
• Supplement Dates Manufacturer Received: 05/02/2016
• 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): Other