BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MMRNA

    MDR report key: 12869072 · Received November 23, 2021

    Report

    Report Number
    MW5105562
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    May 12, 2021
    Report Date
    November 22, 2021
    Manufacturer
    VIVOS THERAPEUTICS INC.
    Product Code
    LQZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763280 MMRNA DEVICE, JAW REPOSITIONING LQZ VIVOS THERAPEUTICS INC. MRNA CUSTOM MADE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male AMBIEN| B-VITAMINS| FISH OIL| GRAPE SEED OIL| MAGNESIUM| MIRTAZIPINE (OCCASIONALLY)| MULTI-VITAMINS| OTHERS INTERMITTENTLY: VITAMIN C| RESVERATROL | TAMSULOSIN (OCCASIONALLY)| THUMB BRACES| VEGAN PROTEIN POWDER| VITAMIN D| ZINC