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

Catalog Number 7510800

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

Patient Problems Cyst(s) (1800); Pain (1994); 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.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) 2009: patient got admitted with the following pre-op diagnosis: degenerative disc disease, spinal stenosis and mechanical back pain at l5-s1, with right-sided radicular symptoms.Patient underwent the following procedures: decompression of l5-s1, right side, for the purpose of alleviating stenosis and sciatic pain.Posterolateral fusion l5-s1 with autologous bone and bmp.Posterior segmental fixation l5-s1 using vane instrumentation.Posterior lumbar interbody fusion l5-s1 using depuy interbody cages and autologous bone and bmp.Harvest of marrow from the sacrum for the purpose of obtaining bone graft material.Injection of intrathecal fentanyl for post-op analgesia.Use and interpretation of intra-op fluoroscopy.Per op-notes, "again this was mixed with local autologous bone and later sponges and rhbmp-2.Between the two cages we did place some additional local autologous bone and a small amount of rhbmp-2 on a collagen sponge.Fit and fill of the cages was good.We then grafted the posterolateral gutters using the remaining autologous bone and rhbmp-2 with collagen." no intra-op complications were reported.(b)(6) 2015: patient, who had previously undergone plif, had developed severe back and bilateral leg pain, worse on the left.Patient got admitted with the following pre-op diagnosis: spinal stenosis at l4-5, status post previous posterior lumbar interbody fusion at l5-s1 with facet arthropathy and synovial cyst on the right.Patient underwent the following procedures: lumbar laminectomy with removal of epidural non-neoplastic lesion (synovial cyst) using microsurgical techniques with placement of coflex interspinous device.Intra-operative electrophysiologic monitoring with somatosensory-evoked potential, electromyogram and electroencephalogram monitoring with real time reading neurologist, audio connection and screen sharing.Per op-notes: "there was severe lateral recess compression on the left.There was a synovial cyst on the right, which was dissected free with the dissector and removed in its entirety.".

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: 5633362
• MDR Text Key: 44450263
• Report Number: 1030489-2016-01331
• 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: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510800
• Device Lot Number: M110810AAQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2016
• 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