BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMILE DIRECT ALIGNERS

    MDR report key: 10114472 · Received June 2, 2020

    Report

    Report Number
    MW5094813
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Date of Event
    May 11, 2020
    Report Date
    June 1, 2020
    Manufacturer
    SMILE DIRECT / ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I'M A VICTIM OF SMILE DIRECT. IT WOULD'VE BEEN MORE OF A DISASTER IF I DIDN'T MENTION TO MY DENTIST THAT I WAS USING THEIR ALIGNERS. I'M CAVITY PRONE AND SMILE NEVER EVEN RECOMMENDED TO ME THAT I HOLD OFF UNTIL I SEE MY DENTIST OR ORTHODONTIST. KNOWING THAT IT COULD MESS MY TEETH UP EVEN MORE BUT NOT TELLING ME, THEY CONTINUE TO TAKE (B)(6) OUT OF MY ACCOUNT EVERY MONTH. IT'S SCARY THAT THIS COMPANY IS STILL LIVE AND ABLE TO CONTINUE TO RUIN MORE PEOPLE'S LIVES. I'VE REQUESTED A REFUND FROM THEM BUT I HAVE YET TO HEAR FROM THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574424 SMILE DIRECT ALIGNERS ALIGNER, SEQUENTIAL NXC SMILE DIRECT / ALIGN TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR