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 Headache (1880); Neuropathy (1983); Pain (1994); Weakness (2145); Burning Sensation (2146); Stenosis (2263); Distress (2329); Injury (2348); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

(unanticipated bone growth, revision surgery).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) 2015, patient underwent left l4-5, l5-s1 transforaminal lumbar interbody fusion in which rhbmp-2 was implanted.Allegedly, post-op patient suffered with inappropriate bone growth resulting in bone impinging on patient's nerves and continued to experience pain.Patient allegedly suffered with debilitating injuries requiring surgical intervention, mental anguish and distress, injuries requiring extensive medical treatment.

Event Description

It was reported that on: (b)(6) 2015: patient presented with following pre-op diagnoses: l4-5, l5-1 degenerative disk disease.For which, patient underwent following procedures: left l4-5, l5-1 transforaminal lumbar interbody fusion (tlif), arthrodesis l4, l5, s1 using recombinant bone morphogenic protein type 2, pedicle screw instrumentation bilaterally l4, l5, s1, peek interbody devices l4-5, l5-s1, microdissection, fluoroscopy and nerve integrity monitoring.Per op notes, a peek interbody device was selected.Recombinant bone morphogenic protein type 2 was mixed and distributed amongst several collagen sponges per the manufacturer¿s recommendations.Local autograft was then rolled into two of these sponges, and these sponges were inserted into the intervertebral disk space and pushed to the contralateral side.A third bone morphogenic protein- coated collagen sponge was then rolled into the center of the interbody device and the interbody device was inserted carefully under direct visualization.Its position was checked fluoroscopically.Patient tolerated the procedure well without any intraoperative complications.On (b)(6) 2015: patient got discharged with discharge diagnosis as: lumbar herniated nucleus pulposus with myelopathy.Lumbar spondylosis with myelopathy.On (b)(6) 2015 the patient underwent mri of the cervical spine.Impression: multilevel spondylosis with a few levels of stenosis, stable.Stable postoperative fusion changes and alignment abnormalities.On (b)(6) 2015 the patient was presented for office visit with pain in neck, back and arm.Assessments: spinal stenosis in cervical region, cervical spondylosis with myelopathy, cervicalgia, brochial neuritis or radiculitis.On (b)(6) 2015: patient presented with a x-ray exam of (three view )lumbar spine.Impressions: degenerative changes lumbar spine with previous fusion.On (b)(6) 2015 the patient was presented for office visit with low back pain with radicular features.Problems: spinal stenosis in cervical region, brachial neuritis or radiculitis, cervicalgia, thoracic or lumbosacral or radiculitis and lumbago.On (b)(6) 2015: patient presented with an office visit and underwent a physical examination.Impression: there is an underlying peripheral polyneuropathy that is primarily sensory.Positive changes post-operatively include the return of his left tibial h-reflex (s1).It is however of a diminished penetrance, decreased in amplitude and of an increased latency.Right lower extremity emg finds denervation changes isolated to the gluteus medius (l4, l5 and s1 root levels).Left lower extremity emg finds the following: 2+denervation changes about gluteus medius and milder denervation changes to the tibials anterior and peroneus groups (l5).Left posterior calf fasciculations are stable.There is a significant decrease in the number of motor units recruited for all muscles tested.This parallels give-way pattern of weakness to muscle testing exam.On (b)(6) 2015: patient presented with an mri of lumbar spine without and with contrast due to back pain.Impressions: post-surgical and degenerative changes seen predominantly in the lower lumbar spine.On (b)(6) 2015: patient was presented for office visit with complaints of increased changes in sensation, increased weakness, and increased in pain in his left lower extremity.Associated symptoms: cervical pain, bilateral upper extremity weakness and pain, lumbar pain, bilateral lower extremity pain, migraines.Assessments: the patient has shown severe progression in changes in sensation in his left lower extremity with progression in weakness of his left foot.Patient has increased in pain and complaints of a ¿shock wave¿ sensation i his left foot.Spinal stenosis in cervical, cervicalgia, spinal stenosis of lumbar region, lumbago.On (b)(6) 2015: patient was presented for office visit for follow up.Assessments: the patient has been ordered lab work and a left l5 epidural si injection due to osteoclastic cavitation around the capstone stages at both levels.There was fluid collection on the left which impinges on the l5 nerve root.On (b)(6) 2015: patient presented with a bone densitometry exam due to a history of non-union with fracture (suspected osteoporosis).Impressions: there is a moderate to severe degree of osteopenia in the right hip with mild to moderate changes on the left.On (b)(6) 2015: patient underwent a radiology exam of lumbar spine with 2 or 3 views.Impressions: stable fusion findings.On (b)(6) 2015, (b)(6) 2016: the patient was presented for office visit for routine follow up.Current problem list includes depressive disorder, spinal stenosis, brachial neuritis, spinal stenosis, thoracolumbar syndrome, cervical radiculopathy, lumbar radiculopathy and headache.Assessments: lumbar stenosis, c5-6 radiculopathy and cervical stenosis.On (b)(6) 2016: the patient underwent ct scan of the lumbar spine.Impression: status post multilevel anterior posterior fusion from l4 through s1 with pedicle screws and rods and bone grafts.Significant right sided foraminal narrowing at l4-5 with moderate right sided foraminal narrowing at l5-s1 caused by facet hypertrophy and some settling of the discs.On (b)(6) 2016: the patient was presented for office visit for follow up on ct scan of the lumbar spine dated (b)(6) 2016.Assessments: the ct of the lumbar spine revealed status post multilevel anterior posterior fusion from l4 through s1 with pedicle screws and rods and bone grafts.Significant right sided foraminal narrowing at l4-5 with moderate right-sided foraminal narrowing at l5-s1 caused hypertrophy and some settling of the discs.On (b)(6) 2016: patient presented with a follow-up visit due to lower back pain down bilateral legs to toes.Patient was assessed with following: lumbar spondylosis with myelopathy.Headache, migraine.Cervical radiculitis.Cervical spinal stenosis.Patient underwent following procedures: right transforaminla lumbar epidural steroid injection.Right transforaminal lumbar epidural steroid injection.On (b)(6) 2016: patient presented with follow-up visit due to escalating foot pain, paresthesia and deteriorating distal left lower extremity function with inability to actively dorsiflex left ankle.Patient underwent physical examination and emg/nerve study.Impressions: electrodiagnostics slowly transition to a more polyneuropathic experience.Certainly he has an underlying sensory neuropathy.We assume he has undergone lab assay as pertinent to same.Other ¿negatives¿ include: left tibial h-reflexes once again ¿lost¿.Right lower extremity finds fasciculations about the anterior and posterior calves and 1+ deviation changes about right hamstrings and gluteus medius, i.E.L5-s1 distributions.Left lower extremity finds fairly stable s1 greater than l5 chronic changes and fasciculations.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6597219
• MDR Text Key: 76127083
• Report Number: 1030489-2017-01376
• 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,Followup
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: 7510800
• Device Lot Number: M111401AAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2014
• 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; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 102