MMRNA

Description of Event or Problem

I STARTED USING A VIVOS ORAL APPLIANCE IN THE SPRING OF 2021. GUIDANCE FROM THE PROVIDER SAID TO WEAR IT 14 TO 16 HOURS PER DAY. AFTER WEEKS OF WEARING IT, THE LEFT SIDE OF MY JAW BEGAN TO LOCK AND CHEWING SOME FOODS, LIKE PIZZA CRUST, BECAME NOISY AND PAINFUL, SO I STOPPED WEARING THE APPLIANCE. I DID NOT CONTACT THE PROVIDER BECAUSE THE DENTAL PROVIDER IN (B)(6) ALSO HAPPENED TO BE THE FATHER OF MY WIFE'S MANAGER AT (B)(6). NOW THAT SHE AND I ARE SEPARATED, AND GIVEN THAT MY LEFT JAW JOINT SEEMS SWOLLEN AND PERMANENTLY DAMAGED, I AM REPORTING THIS PROBLEM. FDA SAFETY REPORT ID # (B)(4).