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

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

Patient Problems Ossification (1428); Apnea (1720); Cerebrospinal Fluid Leakage (1772); Dysphagia/ Odynophagia (1815); Headache (1880); Hematoma (1884); Muscle Spasm(s) (1966); Neurological Deficit/Dysfunction (1982); Pain (1994); Numbness (2415); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

Although it is unknown if the device caused or contributed to the reported event or not, we are filing this report for notification purposes.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.If information is provided in the future, a supplemental report will be issued.

Event Description

The event details listed were obtained on (b)(6) 2018 per the cer "(b)(4)- cer for cervical disk replacement devices- (b)(6) 2017" conducted from a data set which contained a multi literature article review, which could contain duplicated information obtained from other literature articles.The complications associated with the cervical disc observed during a review of literature articles published in different years as reported in the cer could be summarized as below: it was reported that revision surgery due to treatment failure occurred in 43 patients.Dysphagia was reported in 65 patients.Dysphonia was reported in 64 patients, re-operation occurring in 25 patients, numbness reported in 3 patients, neurological event including back and leg pain reported in 2 patients, sleep apnea reported in 1 patient, bursitis reported in 2 patients, spinal fluid leak reported in 2 patients, headache reported in 3 patients, muscle spasm reported in 2 patients, venous bleeding occurred in 1 patient, lhermitte phenomenon occurred in 1 patient, hematoma occurred in 2 patient, heterotopic ossification in 28 patients and neck and arm pain in 1 patient.

• 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: 7380732
• MDR Text Key: 103780281
• Report Number: 1030489-2018-00482
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2018
• 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