MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK PRESTIGE CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC

Device Problem Mechanical Problem (1384)

Patient Problems Headache (1880); Neuropathy (1983); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is not returned to manufacturer for evaluation however imaging films are received.A follow up report will be sent when the results of image review is received.

Event Description

It was reported that on (b)(6) 2008: the patient presented with left arm pain, left herniated nucleus pulposus, c6-7 and underwent the following procedures: anterior cervical diskectomy, c6-7.Anterior arthroplasty, c6-7.Per operative report: after excellent decompression, endplates were drilled to be in a parallel fashion.Trials were used and a 7 x 18 mm disk was found to be of satisfactory size.The anterior osteophytes were removed and cervical disc of this size was deployed in the interspace.Bone screws were then placed.A locking screw was placed.The neck was brought through motion and this demonstrated excellent motion of device.There were no intraoperative complications.On (b)(6) 2014: patient underwent ct of lumbar spine due to low back pain and leg pain.Impression: status post laminectomy l4-5.Broad based disc bulge l4-l5 eccentric to the left.Moderate left foraminal stenosis, mild right foraminal stenosis, mild right foraminal stenosis l4-l5.On (b)(6) 2015: patient underwent ct of cervical spine without contrast due to neck pain.Impression: old surgical change c6-7.Minimal cervical spondylosis, stable from previous examination.On (b)(6) 2016: patient underwent x-ray of cervical spine due to neck pain.Impression: 2 mm retrolisthesis of c4 on c5 with hyperextension and postoperative changes of artificial disc prosthesis at c6-7.Hardware appears intact.On (b)(6) 2017: patient presented with neck pain and low back pain.Diagnosis: cervical radiculopathy, cervical facet arthropathy, lumbar post laminectomy syndrome, lumbar foraminal stenosis and chronic pain disorder.Patient has failed artificial disc with progressive worsening neck pain which is likely from c5-6 where there is retrolisthesis and significant left c5-6 arthrosis.The patient still reported ongoing debilitating symptoms which limited the quality of life and functional activities including household works.Anterior cervical discectomy fusion/instrumentation at c5-6 was recommended.Reportedly, the patient had 2 previous lumbar surgeries and 2 revisions "scs " with progressive worsening of symptoms.This interferes with his "alds" and the current scs did not provide him much relief.Images of his lumbar spine were reviewed with him and it is possibility that his symptoms could be from l4/5 and/or l5-s1 level.Ct discogram l4-5 and l5-s1 was recommended to find out the pain source.On (b)(6) 2017: patient presented with long term neck and radicular pain accompanied by numbness.Images show cervical kyphosis with he terotrophic ossification at c6-7 and degenerative disc disease at c5-6.The patient was not satisfied with the care and went to germany for treatment.Post the implantation surgery, the patient had been suffering with pseudo-radicular neck pain, radicular pain both sides, non-responsive to previous treatment.Post-op, the patient was in too much pain going down his hand, headaches, difficulty breathing, difficulty holding hand upright and observed neurological symptoms.He was treated as an in-patient from (b)(6) 2017.On (b)(6) 2017: the patient presented with hypo mobility of prosthesis degenerative vertical segmental instability c5/6 and underwent removal of cervical disc c6/7, decompression, c6/c7, nucleotomy, mobilization of segments c5/c6, implantation of a total disc replacement at segments c5-c7.Post-operative course was uneventful- re-mobilization with a soft cervical collar; primary wound healing.X-ray showed correct implant positioning and a good restoration of the disc height and vertebral alignment.

Manufacturer Narrative

Additional information: image review image review: "patient with multiple spinal surgeries(cervical and lumbar) complains of neck pain at multiple visits.C6-7 arthroplasty performed in 2008 and revised in 2017 to two level construct c5-6 and c6-7 with different manufacturer disc.Provided images are x-ray only and not dynamic films, but multiple ct myelogram and physicians deemed the construct and hardware to be stable.Called a failed c6-7 artificial disc 2 degree heterotropic ossification by the most recent surgeon who performed the revision procedure.Long term data regarding the fusion rates of this device are still relatively scant, but this likely to be patient specific factors.".

Event Description

It was reported that the patient never had a fusion procedure prior to the reported surgery.There was a fusion anomaly of a facet joint in the lumbar spine in the area of microdiscectomy.But the patient did not have a fusion surgery at any level.On (b)(6) 2016 was the first indication from a doctor that the patient's adr was fused, which was heterotopic ossification.The fusion placed the device in the closed position, which was kyphosis, open in the posterior (bone) and closed in the anterior.Fusion was there due to the device not moving.

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: PRESTIGE CERVICAL DISC SYSTEM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6607246
• MDR Text Key: 76498704
• Report Number: 1030489-2017-01435
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• 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

• 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: 05/09/2017
• Initial Date FDA Received: 06/02/2017
• Supplement Dates Manufacturer Received: 06/28/2017; 06/28/2017
• Supplement Dates FDA Received: 07/25/2017; 10/04/2017
• 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; Required Intervention
• Patient Weight: 68