FDA Adverse Event
Injury
Summary report: N
TMJ IMPLANT FOSSA
MDR report key: 1212049
·
Received October 24, 2008
Report
- Report Number
- MW5008780
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- October 24, 2008
- Report Date
- October 24, 2008
- Manufacturer
- TMJ IMPLANTS, INC.
- Product Code
- LZD
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
TMJ IMPLANT FOSSA DEVICES IMPLANTED BILATERALLY IN 1991. NOW EXPERIENCING A LOT OF PAIN AND INFLAMMATION IN THE FACE, EAR, AND HEAD. SYMPTOMS HAVE BEEN PRESENT OVER THE PAST TWO MONTHS. IN THE PAST, MEDICATIONS HAVE HELPED DECREASE THESE TYPE OF SYMPTOMS, BUT NOTHING IS WORKING THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TMJ IMPLANT FOSSA | CHRISTENSEN FOSSA | LZD | TMJ IMPLANTS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other| R |