FDA Adverse Event
Injury
Summary report: N
PRESTIGE CERVICAL DISC SYSTEM
MDR report key: 4200538
·
Received October 24, 2014
Report
- Report Number
- 1030489-2014-04128
- Event Type
- Injury
- Date Received
- October 24, 2014
- Date of Event
- January 25, 2010
- Report Date
- June 3, 2010
- Manufacturer
- WARSAW ORTHOPEDIC, INC.
- Product Code
- MJO
- PMA / PMN Number
- P060018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE FOR IMPLANT OF ARTIFICIAL CERVICAL DISC AT C6-C7. AT 85 MONTHS POST-OP, PATIENT REPORTS AN INCREASE OF NECK PAIN. REVIEW OF FILMS SHOW FUSION AT THE IMPLANT LEVEL. SUBSIDENCE OF THE DISC IS NOTED AT C6 WITH BRIDGING BONE POSTERIORLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678461 | PRESTIGE CERVICAL DISC SYSTEM | PROSTHESIS, INTERVERTEBRAL DISC | MJO | WARSAW ORTHOPEDIC, INC. | NA | 135420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00039 YR | Disability | BONE SCREWS, LOCKING SCREW |