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

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

Patient Problems Ossification (1428); Dysphagia/ Odynophagia (1815); Inflammation (1932); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Respiratory Distress (2045); Weakness (2145); Osteolysis (2377); Patient Problem/Medical Problem (2688); No Code Available (3191)

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 the patient underwent a transforaminal lumbar interbody fusion using rhbmp-2/acs with a metal cage.The patient's post-operative period was marked by severe pain.Following the surgery, the patient suffered from autonomic neuropathy, small fiber neuropathy, peripheral neuropathy, muscle atrophy and nerve damage, inflammatory reactions, chronic radiculitis, osteolysis (bone resorption), displacement or migration of the spacer cage, pseudoarthrosis, dysphagia, difficulty breathing, difficulty gripping and holding items, and chronic pain.The patient now suffers from severe injuries and damages, including bone overgrowth causing nerve compression, chronic pain and radiculitis.

Manufacturer Narrative

Per review of the images, the findings are: (b)(6) 2007 cardiac us no spinal pathology imaged (b)(6) 2007 mammogram no comment (b)(6) 2007 brain mri no spinal pathology imaged (b)(6) 2008 ap pelvis and ap lumbar verify spondylolisthesis at l5.Si joints and hips show no sign of arthritis or deformity.Lumbar spine is straight with five lumbar vertebrae (b)(6) 2009 abdominal ct contrasted study shows the axial skeleton.Bilateral pars defects are seen at l5.Advanced degenerative disc disease is seen here also with some vacuum disc changes noted.(b)(6) 2010 lumbar mri sagittal t2 images show a grade one spondylolisthesis at l5.Desiccation is seen at both l4 and l5.There is a central hnp behind l5 that appears sequestered from the l5 disc.Cysts are apparent around the left l5 facet.Axial views verify the pars defects with persistence of the central canal.Foraminal stenosis is noted in both l5 root foramina.(b)(6) 2010 mammogram no comment chest x-ray ap and lateral views show normal cardiac, pulmonary bony anatomy.Dorsal spine appears to show normal kyphosis with minimal degenerative disc changes.(b)(6) 2010 lumbar x-rays 4 views verify grade one isthmic spondylolisthesis with bilateral pars defects at l5.Sclerosis of endplates is noted at l5/s1 (b)(6) 2010 lumbar x-rays these films are taken during spinal fusion surgery.Sequential images show placement of pedicle screws and rods in l5 and s1.Quality of images is limited.(b)(6) 2010 postmyelogram ct verifies full decompression at l5/s1 with crescent interbody spacer and posterolateral bone graft.Screws are well positioned in s1 but penetrate the lateral l5 body on the left.No heterotopic bone or neural compression is noted.Fusion appears to be incomplete.(b)(6) 2014 ct lumbar spine post operative ct shows l5-s1 fusion with interbody device present at l5 s1 disc space.Solid bony fusion at the interbody space and lateral elements is present.Intrumentation appears to be placed appropriately at both levels with the l l5 screw having bicortical purchase.No evidence of hardware failure.Bony foraminal stenosis is present at the l5 level bilaterally right side worse than left side.Impression: post operative imaging shows solid bony fusion at the operated level without evidence of hardware failure or adjacent level deformity.No preoperative or early postoperative imaging is available for review to asses the degree of foraminal stenosis or progression of any bony impingment on neural elements.Per report the patient suffers from numerous complaints remote to the level of surgery including respiratory difficulties, dysphagia, and upper extremity complaints.No history of bmp hypersensitivity is given to explain these remote adverse events.Local application of bmp at the l5-s1 space would be unlikely to cause these events outside of a systemic hypersensitivity.Root cause: surgical technique, patient specific.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3663669
• MDR Text Key: 19390005
• Report Number: 1030489-2014-01569
• 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: 05/15/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 03/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2015
• 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