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

Catalog Number 7510100

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

Patient Problems Neuropathy (1983); Pain (1994); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 presented with post laminectomy syndrome with recurrent spinal stenosis, l4-l5.Foraminal stenosis, l4-l5.Disk herniation contributing to stenosis, l4-l5.The patient underwent the following procedures: posterior bilateral redo lumbar laminectomy discectomy, l4-l5, decompression of neural elements.Transforaminal posterolateral fusion, l4-l5.Placement of biomechanical device, l4-l5.Bilateral pedicle screw instrumentation arthrodesis, l4-l5.As per-op notes, ".Endplates were prepared.Bone graft was placed impregnated with bone marrow, protecting the neural elements and passed the peek cage, with bmp in the disk space of l4-l5, protecting the neural elements." the patient was in stable condition.On (b)(6) 2014: the patient underwent ct myelogram which revealed moderate central canal stenosis due to facet arthropathy and annular bulging.On (b)(6) 2014: the patient underwent ct san which revealed neural foraminal stenosis bilaterally at l4-5, postsurgical changes at l4-5 with hardware noted at l4-5 bilaterally, at the adjacent level at l3-4 there was severe central canal stenosis.On (b)(6) 2014: the patient presented with post-laminectomy syndrome where the patient had a previous laminectomy at the l4-l5 level and continued to have persistent pain in the l4-l5 distribution.Spinal stenosis with continued stenosis at the l4-l5 level and also adjacent level stenosis at the lumbar 3 and lumbar 4 level with compression of both the exciting l3 nerve root due to facet arthropathy and the traversing l4 nerve root due to facet arthropathy and ligamentum flavum hypertrophy.Lumbar radiculopathy.Progressive decline in ability to perform activities of daily living.Failure of non-operative treatment.The patient underwent the following procedures: laminectomy for decompression of the l3 nerve root.Additional level laminectomy for decompression of the l4 nerve root.Additional level decompression and laminectomy to decompress the l5 nerve root.Posterolateral inner transverse process fusion where l3-l4 was fused due to intra-operative introgenic instability.Non-segmental pedicle screw instrumentation with bilateral pedicle screws placed at l3 and l4 for fixation.Exploration of fusion, which was done at l4-l5 level.The patient had persistent back, buttock, and leg pain.Removal of non-segmental pedicle screw fixation.Utilization of allograft and allograft chips for structural support.Utilization of laminectomy bone taken from the same incision, cleaned and morselized and used for posterolateral inter-transverse process fusion at l3-l4.Final interpretation of fluoroscopic images taken via fluoroscopy intra-operatively and described.No patient complications were 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: 5699988
• MDR Text Key: 46563038
• Report Number: 1030489-2016-01633
• 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: 05/09/2016

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: 05/31/2013
• Device Catalogue Number: 7510100
• Device Lot Number: M111116AAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 06/05/2016
• Supplement Dates Manufacturer Received: 05/09/2016
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2012
• 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