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 Pain (1994); Swelling (2091)

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.

Event Description

It was reported that on: (b)(6) 2006: pre-op diagnosis: spinal stenosis, degenerative disc and spondylolisthesis.Postop diagnosis: fractured facet.Procedure: l5 gill laminectomy.Re-do right l4-5 foraminotomy.Transforaminal lumbar interbody fusion, two levels l4-5 and l5-s1.Interbody device legacy.Posterolateral fusion two levels l4-5 and l5-s1.Legacy bone screws, bmp, local bone grafting.Per operative notes: patient was taken to operating room and placed on the operating room table.The back was then prepped and draped in usual sterile fashion.Skin incision was made over the l4 to s1 spinous processes and taken down through subcutaneous tissue sharply.Subperiosteal dissection of the l4-5 and s1 lamina was performed.Dissection was then carried over the l4 and l5 facets and the l4-l5 and transverse processes and sacral ala were subperiosteally dissected bilaterally.Patient had loose posterior element of l5 with a fractured facet on right side and a pars defect on the left.At this point a gill l5 laminectomy was performed.At this point a right sided r e-do foraminotomy and hemilaminectomy was completed at l4-5 removing the entire inferior facet of l4 and exposing the l4 and l5 nerve roots completely.One adequate decompression had been noted, peg hole screws were placed on right side at l4-5 and s1 and distraction being performed between l4 and l5 disc through pedicles.Annulotomy was performed in l4-5 disc and all disc material was removed from l4-5 disc.The end plates were curetted back to bleeding bone in standard fashion.The anterior one half of disc was packed with bmp and morselized bone graft and in midportion of disc, peak cage packed with bmp was placed in interbody device.At l5-s1, distraction was being performed, and while protecting l5-s1 nerve roots an annulotomy was performed.The end plates were curetted back to bleeding bone and again anterior half of disc was packed with morselized bone graft mixed with bmp.In the midportion of disc, peak cage packed with bmp was placed in interbody device.Once this had been done on left side, decortication was performed of transverse processes of l4, l5 and s1 and remaining bone graft mixed with bmp in anchovy type technique and placed along left lateral gutter.On (b)(6) 2006: patient presented for follow up with a little swelling around the wound.Patient was recommended an x-ray of lumbar spine.On (b)(6) 2006: patient presented for follow up with swelled wound.On (b)(6) 2006: patient presented for follow up.On (b)(6) 2006: patient presented for follow up.On (b)(6) 2007: patient presented for follow up with little sharp pain in her low back.On (b)(6) 2007: patient presented for follow up with severe right leg pain.Patient was recommended a mri of lumbar spine.On (b)(6) 2007: a study on the mri of lumbar spine without contrast was performed.Impression: prior surgical changes of anterior and posterior lumbar intervertebral fusion at l4-5 and l5-s1.There has been posterior decompression at these levels.The right neural foramen at l4-5 is visualized; the left neural foramen at l5-s1 is mildly narrowed.The neural foramina at l3-4 are mildly narrowed bilaterally.Mild degenerative changes at the hips, right greater than left.There are signal changes surrounding the thecal sac at the postoperative level compatible with granulation tissue.On (b)(6) 2007: patient presented for follow up of mri with right leg pain.Impressions: mri show some mild degeneration of the l3-4 disc with mild foraminal stenosis bilaterally and a little bit of protrusion on right side, for latcral foraminal.On (b)(6) 2007: patient presented for follow up with right shoulder pain and right elbow pain.Patient underwent x-rays.Impressions: right shoulder pain, probably due to some myofasciitis.Right lateral epicondylitis.On (b)(6) 2009: patient presented for follow up with low back pain.On (b)(6) 2011: patient presented with severe back and leg pain.Patient underwent mri of the lumbar spine without contrast due to lumbosacral neuritis.Impressions: postoperative changes of the lumbar spine with solid bony fusion at the level of l4-l5.Mild advanced level degenerative change at the level of l3-l4 with a small right-sided synovial cyst.On (b)(6) 2011: pre-op diagnosis: l3-l4 adjacent segment disease, cyst and spinal stenosis with spinal listhesis.Procedure: l3 sublaminar decompression, bilateral hemilaminectomy and removal of facet cyst.L3-l4 transforaminal lumbar interbody fusion.L3-l4 posterolateral fusion.Screw fixation l3-s1 segmental.Interbody device peek cage x1.Local bone graft.Removal of rod.A study was performed on the l spine 2 vw surg, impression: intraoperative views with fluoroscopy were utilized for tlif.Alignment appears anatomic.On (b)(6) 2011: patient underwent lumbar spine 2 views x-rays.Impression: l3-s1 posterior spinal fusion and decompression change.On (b)(6) 2011: patient presented for follow up.

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: 5594183
• MDR Text Key: 43214019
• Report Number: 1030489-2016-01154
• 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: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• 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: M115004AAK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2016
• 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): Other
• Patient Weight: 72