FDA Adverse Event
Injury
Summary report: N
TMJ FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM
MDR report key: 225967
·
Received June 3, 1999
Report
- Report Number
- 1721760-1999-00017
- Event Type
- Injury
- Date Received
- June 3, 1999
- Date of Event
- April 22, 1999
- Report Date
- May 3, 1999
- Manufacturer
- TMJ IMPLANTS, INC.
- Product Code
- JAZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DEVICES EXPLANTED DUE TO PAIN, MUSCLE SPASMS, AND EXTENSIVE WEAR ON ACRYLIC CONDYLAR HEADS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TMJ FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM Implant | TEMPORMANDIBULAR JOINT PROSTHESIS SYSTEMS | JAZ | TMJ IMPLANTS, INC. | NA | L-(0022)R-(0033) R/LCP(MORE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention |