FDA Adverse Event
Injury
Summary report: N
TMJ CONCEPTS
MDR report key: 3628172
·
Received February 10, 2014
Report
- Report Number
- MW5034426
- Event Type
- Injury
- Date Received
- February 10, 2014
- Date of Event
- February 7, 2014
- Report Date
- February 7, 2014
- Manufacturer
- TMJ CONCEPTS
- Product Code
- LZD
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
I CONTINUE TO EXPERIENCE COMPLICATIONS SINCE MY LAST TMJ IMPLANT SURGERY IN THE SUMMER OF 2013. I HAVE GOOD JAW FUNCTION AND THE PAIN HAS DECREASED, HOWEVER FOR THE PAST SEVERAL MONTHS I'VE ENDURED EXTREME BODY FATIGUE AND LOW-GRADE THAT LAST A WEEK AT A TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88736 | TMJ CONCEPTS | TMJ CONCEPTS | LZD | TMJ CONCEPTS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |