BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMILEDIRECTCLUB

    MDR report key: 9391840 · Received November 27, 2019

    Report

    Report Number
    MW5091368
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    August 1, 2019
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I DON¿T ENTIRELY KNOW IF I¿M WORKING WITH AN ACTUAL DENTIST/ORTHODONTIST, MY JAW IS NOW MISALIGNED WITH MY BITE AND TEETH HAVE SEEMED TO WORSEN, I CAN¿T SEEM TO GET MY MONEY BACK OR GET TO CUSTOMER SERVICE ¿THOROUGHLY¿, STATES I HAVE A DIFFERENT ACCOUNTS AND WILL NOT ISSUE ANY REFUND, WASTING MY TIME, MESSED MY MOUTH UP FOR 2K, JUST STEALING PEOPLE¿S MONEY AND I DON¿T EVEN KNOW IF THEY ARE TRULY LICENSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181993 SMILEDIRECTCLUB ALIGNER, SEQUENTIAL NXC ALIGN TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other