FDA Adverse Event
Malfunction
Summary report: N
TRINICA CERVICAL PLATE SYSTEM
MDR report key: 1016923
·
Received March 20, 2008
Report
- Report Number
- 2184052-2008-00005
- Event Type
- Malfunction
- Date Received
- March 20, 2008
- Report Date
- February 20, 2008
- Manufacturer
- ZIMMER SPINE, INC.
- Product Code
- KWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT (MVA). THE DATE OF THE MVA IS UNK. DURING A POST OPERATIVE OFFICE VISIT, SOMETIME AFTER THE MVA, THE PHYSICIAN DISCOVERED THAT ONE LOCKING CAP WAS BROKEN FROM THE PLATE. NO REVISION SURGERY HAS BEEN PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRINICA CERVICAL PLATE SYSTEM | 71MM CERVICAL PLATE | KWQ | ZIMMER SPINE, INC. | 07.00188.002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |