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