FDA Adverse Event
Injury
Summary report: N
PROPLAST TEFLON TMJ IMPLANT
MDR report key: 32989
·
Received May 13, 1996
Report
- Report Number
- MW1009087
- Event Type
- Injury
- Date Received
- May 13, 1996
- Date of Event
- January 19, 1987
- Report Date
- May 3, 1996
- Manufacturer
- VITEK, INC.
- Product Code
- LZD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
1/19/87 HAD TEFLON TMJ IMPLANT PUT INTO RIGHT TMJ. HAD PAIN, CLICKING, BITE PROBLEMS, HEARING PROBLEMS. EARACHE EVER SINCE ALONG WITH OTHER PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROPLAST TEFLON TMJ IMPLANT Implant | TMJ IMPLANT | LZD | VITEK, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Hospitalization| R |