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 Aspiration Issue (2883)

Patient Problems Pain (1994); Injury (2348)

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) 2011 the patient presented with the following pre-op diagnosis: spinal stenosis at l2, l3, l4, l5, and s1; foraminal stenosis, degenerative disk disease, disk space collapse primarily at l3-l4 and l4-l5; status post prior l4-l5 laminectomy, posterior and far lateral decompression.The patient underwent the following procedures: l2, l3, l4, l5, s1 laminectomy, bilateral recess decompression, foraminotomy with partial facetectomies on the right side and facetectomies on the left side at l3-l4 and l4-l5; l3, l4, l5 bilateral lateral 2-level fusion; l3, l4, l5 bilateral segmental pedicle screw instrumentation using depuy monarch posted screws with band clamps and rods; right iliac crest bone graft through a separate right subfascial skin incision; microdissection of the nerve roots using operating microscope; interpretation of intraoperative x-rays without the presence of radiologist.As per op notes, laminectomy.A laminectomy was performed across 5 levels, l2, l3, l4, l5, and s1.Then, the lateral recess, the foramen, and central canal were all widely decompressed.Partial facetectomies were performed on the right side.Intra-op findings: the patient had degenerative disk disease and stenosis with multiple areas of spur formation and hypertrophy of bone causing areas of nerve compression.At the l4-ls and the l3-l4 region, the patient had prior surgery.There was some scar tissue present.As per op notes, a small straight curette was utilized to separate the scar tissue from the prior laminotomy site.The patient had a facetectomy performed at l3-l4 and at l4-ls to widely decompress the nerves.There did appear to be continued crowding in these regions with nerve compression in these regions.The arthritis was so extensive that the patient did require full laminectomies as well as facetectomies to widely decompress these regions.The intraoperative pathology was fairly impressive as was the degree of arthritis and stenosis present secondary to degenerative disk disease and arthritis.A microdissection was performed using zeiss operating microscope exposing the lateral border, the medial border, the undersurface of the nerve root, the under surface of the thecal sac.All borders of the nerve were quite free and mobile.Pedicle screw instrumentation.Depuy titanium pedicle screws were placed at l3, l4, and l5 bilaterally.After screws were inserted, the pedicles were again assiduously inspected to make sure that the nerves were all quite free and mobile.Depuy band clamps and rods were then utilized to engage the entire construct to make it all quite tight and rigid.Bilateral lateral fusion.A bilateral lateral fusion was performed using autologous iliac crest bone graft supplemented with bone morphogenetic protein rhbmp-2/acs.Interpretation of intraoperative x-rays revealed the patient had good placement of instrumentation of the bone graft.No complications noted.Assessment: the patient has some pathology on the imaging studies that will require further decompression.This includes the l2-l3 area, the l3-l4 area, as well as the l4-l5 area.Further decompression at that level will most likely lead to iatrogenic instability.On (b)(6) 2011 the patient has surgical pain, post lumbar decompression and fusion.The patient underwent ap and lateral lumbar x-rays which reveal excellent placement of the instrumentation and bone graft.Diagnosis: multi level stenosis, recurrent disc herniation and degenerative disc disease aggravated by a motor vehicle accident.On (b)(6) 2011 the patient came for a follow-up status post a lumbar decompression and fusion with real complaint was persistent surgical lumbar pain.Diagnosis: multi level stenosis, recurrent disc herniation and degenerative disc disease aggravated by a motor vehicle accident.On (b)(6) 2011 the patient came for a follow-up and underwent, ap lateral x-rays.Placement of the lumbar instrumentation and the bone graft looks good.The bone graft has not yet consolidated but appears to be in good position as were the screws and hardware.Arthrodesis exists.There was no evidence of any loosening or instability.On (b)(6) 2011 the patient came for a follow-up status post a lumbar revision decompression and fusion, with some residual nerve pain but nothing like what it was pre-operatively.Diagnosis: multi level stenosis, recurrent disc herniation and degenerative disc disease aggravated by a motor vehicle accident.On (b)(6) 2011 the patient came for a follow up visit.He still has some pain with sitting.He did have a little flare up of sciatica recently.His x-rays look good and reveal good incorporation of the bone graft.On (b)(6) 2011 the patient underwent ap lateral lumbar x-rays which reveal to have good placement of the lumbar instrumentation with excellent incorporation of the bone graft.It appears a solid arthrodesis exists.There was no evidence of loosening.On (b)(6) 2011 the patient came for a follow-up.He still has some residual symptoms but nothing like what they were pre-operatively.On (b)(6) 2011 the patient underwent ap and lateral lumbar x-rays which revealed excellent placement of lumbar instrumentation identifying bilateral bone grafting and pedicle screws.There was no evidence of any loosening.The bone graft appeared to be incorporating very well.On (b)(6) 2011 the patient came for a follow-up status post a lumbar revision decompression and fusion.He has no residual sciatica.His only residual complaint appears to be some lumbosacral pain at the bottom of the scar.On (b)(6) 2011 the patient came for an office visit due to flare up of back pain.His x-rays reveal a good fusion.There were no nerve root tension signs and no focal neurologic deficits.On (b)(6) 2012 the patient presented with back pain around the area of surgery.On (b)(6) 2012 the patient came for an office visit post-op due to persistent pain over the old surgical site.Inspection and examination of the back reveal that he has developed some exquisite tenderness over the area of the screws.By examination, he appears to have developed bursitis over the screws.His x-rays otherwise look good.On (b)(6) 2012 the patient came for an office visit post-op due to residual symptom mild lower back pain and some stiffness.On (b)(6) 2012 the patient came for an office visit status post a lumbar decompression and fusion.He was contemplating removal of hardware to help with some of the residual musculoskeletal complaints.On (b)(6) 2012 the patient underwent ap lateral flexion extension lumbar x-ray.It revealed excellent placement of the lumbar instrumentation with good incorporation of the bilateral lateral fusion.There was no evidence of any loosening of the screws on ap lateral or flexion extension x-rays.There appears a solid arthrodesis and no evidence of any loosening exists.On (b)(6) 2012 the patient came for a follow-up due to residual back pain and stiffness due to instrumentation.X-rays were taken which revealed good incorporation of the fusion with no evidence of any loosening.There was no adjacent level instability or pathology identified.On (b)(6) 2013 the patient underwent 2 view ap lateral flexion extension x-rays to confirm a solid fusion with no instability or adjacent level pathology.The patient does have arthritis.On (b)(6) 2013 the patient came for a follow-up; was diagnosed status post instrumented fusion l3, 4 and 5 with tenderness around the instrumentation.

• 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: 5046637
• MDR Text Key: 24771716
• Report Number: 1030489-2015-02152
• 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
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2013
• Device Catalogue Number: 7510800
• Device Lot Number: M111054AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2011
• 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