MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. BRYAN CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Headache (1880); Muscle Weakness (1967); Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

Only month and year valid.Product was not 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

It was reported that in (b)(6) 2015, the patient underwent a disc replacement surgery at c5-c6.On an unknown date, post-op, the implanted disc slid forward.Allegedly, the patient also experienced extreme muscle weakness/atrophy in left arm with pain on both left and right, chronic and severe headaches, muscle pain in entire upper back and neck, limited range of motion in head movement in all directions and he had to sleep in an upright incline position.Reportedly, the patient had two surgeries in 2015, the dates of which are unknown.The implant still remains implanted in the patient; and it is unknown if there would be any revision surgery conducted.

Manufacturer Narrative

X-ray review results: post-op x-rays for c5-c6 cervical disc replacement are received.Flexion-extension views are provided.There is mild anterior translation of the device, which does not seem to change with dynamic motion.Lateral views only are seen.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRYAN CERVICAL DISC SYSTEM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9539573
• MDR Text Key: 173687348
• Report Number: 1030489-2020-00009
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2020
• 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 Age: 55 YR