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 Arthritis (1723); Pain (1994); Burning Sensation (2146); Dizziness (2194)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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.

Event Description

It was reported that on: (b)(6) 2010, the patient was admitted with stenosis.She underwent lumbar decompression and fusion.Per op notes, bilateral lumbar laminectomy l3-5; hardware removal and explore fusion l4-5; posterior spinal fusion bmp and mosaic l3-4; spinal instrumentation at l3-4.During the procedure, the low back was sterilely prepped and draped.Previous midline incision was made.Subperiosteal dissection exposed the spinous process, lamina, facet joint, transverse process from l3 to l5.Deep retractors were placed.The old hardware was identified, dissected around and removed.The corners of the facet of l2-3 and l3-4 were removed with leksell rongeurs and pedicle probes were introduced into the pedicles of l3 and l4 and tapped to 5 mm.Bone morphogenic protein and mosaic were packed in the posterolateral elements.6 x 45 mm expedium screws were placed in the pedicles of l3 and l4.Appropriate size prebent rod was chosen and tightened down.All connections were checked and double checked with the torque device.The nerve roots were inspected and found to be free patient underwent laboratory examinations for evaluating his diabetes.Ct / x rays were performed during the procedure to keep track of the surgery and implant placement.On (b)(6) 2010, the patient presented for the follow up.She had increased pain, burning sensations.She requested for medicine refill.On (b)(6) 2010, the patient underwent lumbar spine ap and lateral.Impression: no significant interval change in the appearance of the lumbar spine.Lower laminectomy and fusion.Stable postoperative changes.16 may 13 ct scan reviewed significant foraminal encroachment at l1-2 <(>&<)> l2-3.Fusion at l3-4 looks good with no foraminal encroachment.On (b)(6) 2013 the patient presented with dizziness, arthritis, insulin dependent diabetes.On (b)(6) 2013, the patient underwent ct lumbar spine with reconstructed images.Lumbar fusion 2010.Post-laminectomy syndrome lumbar spinal stenosis, back pain and right lower extremity pain.Hip pain.Conclusion: progression of degenerative changes at l2-3 comparing to the prior study.Lateral recess stenosis and canal stenosis.Broad based inferior foraminal encroachment; post-surgical changes l3-4 have occurred since the prior study.There was a laminotomy and fusion with posterior instrumentation.Solid bony fusion is present; previous fusion l4-5 and l5-1 as detailed above.On (b)(6) 2013, the patient had cr exam of lumbar spine.Conclusion: degenerative changes l2-3.; on (b)(6) 2013, the patient presented for the follow up and she was experiencing pain in lower lumbar area.Ct scan demonstrated severe degenerative changes at l2-3 above the prior level of fusion.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5159831
• MDR Text Key: 28674997
• Report Number: 1030489-2015-02735
• 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
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2012
• Device Catalogue Number: 7510400
• Device Lot Number: M110806AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/30/2009
• 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
• Patient Weight: 109