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

Catalog Number 7510600

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

Patient Problems Ossification (1428); Neuropathy (1983)

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) 2011: the patient was pre-operatively diagnosed with: pseudoarthrosis.Stenosis, l4-5.Lumbar radiculopathy.He underwent the following procedures: removal of hardware.Decompression laminectomy, foraminotomy and partial facetectomy, l4-5.Posterior spinal fusion, l4-5.Use of local bone, allograft and bmp.Vane instrumentation applied.Removal of old hardware.As per op-notes,¿ after verifying levels, the old hardware was exposed.Again, due to the trajectory, this was a very difficult trajectory to perform.After making initial exposure to remove the old hardware, the rod, cap and screws were removed.At this point, new trajectories were made for all screws to get better purchase and then these were left open, at which point, the lateral gutters and pars were then exposed.Next, the overlying scar tissue and dura was then debrided and there was a dural bleb which was encountered in the decompression which was over sewn with a 6-0 silk.After securing the dural bleb, this was the completion of the decompression again with a fair amount of the lamina which was resected, as well as a thickened flavum facet complex and 4 and l5 roots were traced to their respective foramen to verify adequacy of decompression.Next, the gutters were decorticated, the wounds irrigated and screws were then placed, rod secured and then gutters grafted." the patient tolerated the procedure well without any intraoperative complications.On (b)(6) 2012: the patient was pre-operatively diagnosed with: status post lumbar fusion with pedicle screws and rods at l4-5 in the distant past now with a translational subluxation of l3 on l4.High-grade neural foraminal stenosis l3-4, using bilateral radiculopathy right greater than left.He underwent the following procedure: lumbar re-exploration explant pedicle screws and rods at l4-5 extra difficulty secondary being covered with bone overgrowth and severe scarring followed by bilateral laminectomy, facetectomy and diskectomies at l3-4, twin city titanium pedicle screws under fluoroscopic guidance at l3-l4 with extra difficulty due to the scoliosis and misalignment of the spine, posterior lumbar interbody fusion with a peek cage, demineralized bone matrix l3-4 and lateral transverse fusion with locally harvested autologous arthrodesis rhbmp-2 medium set and allograft 10 cm l3-l4.As per op-notes, "under fluoroscopic guidance, surgeon performed the posterior lumbar interbody fusion coming in from the right side.Using a tamp and mallet to impact and countersink the cage at the middle of the disk and the ventral 1/3 of the disk space level.It was done using fluoroscopic guidance.The plate was then in tight position.Surgeon now removed the distracting rod from the patient's left.Surgeon now took the locally harvested autologous arthrodesis and packed it in the lateral gutter with a tamp from the pedicle and transverse of l3 to the pedicle and transverse of l4.Surgeon took the allograft and wrapped 5 cm covered in rh-bmp2 soaked sponge on the right and on the left, impacted this in.This completed the lateral transverse fusion.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7153746
• MDR Text Key: 96002971
• Report Number: 1030489-2017-02589
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843812
• UDI-Public: 00681490843812
• 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
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Catalogue Number: 7510600
• Device Lot Number: M110916AAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2010
• 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; Required Intervention