MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PRESTIGE CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number	6961460
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Outcomes to adverse event - other - hoarseness; problems swallowing; lack of muscle strength in throat; neck spasms; pain in shoulders and upper back; painful breathing; digestive problems; scoliosis; kyphosis; and dysphagia.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 or Problem Description
It was reported that the patient underwent cervical surgery to repair disc bulge in her neck.Post-op, the patient claimed that about 4 years ago she had a fall with a concussion- she had also been involved in two previous auto accidents (rear-ended).Patient is experiencing following problems for about 3 years: hoarseness; problems swallowing; lack of muscle strength in throat; neck spasms; pain in shoulders and upper back; painful breathing; digestive problems.Ct scan finally showed the implanted hardware (disc) in her neck had shifted.She has over time developed scoliosis, kyphosis, and dysphagia.One doctor told her it was inoperable and couldn't be repaired.She then got a second opinion and was told it was operable and her vertebrae needed to be fused at 2 levels, but she is having trouble getting someone to do the surgery.She also claims that doctor initially suggested removal, but now his mind would changed.She was searching for another neurosurgeon to give her an opinion.
Additional Manufacturer Narrative
X-ray review results: post-op, x-rays for c5-6 prestige artificial disc replacement.There is a mild anterior back out of the inferior screw.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PRESTIGE CERVICAL DISC SYSTEM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 9590162
• Report Number: 1030489-2020-00065
• Device Sequence Number: 667322
• Product Code: MJO
• UDI-Device Identifier: 00613994129215
• UDI-Public: 00613994129215
• Combination Product (Y/N): N
• PMA/510(K) Number: P060018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6961460
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No