BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILE DIRECT ALIGNERS

    MDR report key: 9659200 · Received January 31, 2020

    Report

    Report Number
    MW5092681
    Event Type
    Injury
    Date Received
    January 31, 2020
    Report Date
    January 29, 2020
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED SMILE DIRECT CLUB ALIGNERS FOR ORTHODONTIC TREATMENT. THE END RESULT IS THAT I NEED EXPENSIVE CORRECTIVE TREATMENT TO FIX THE MISALIGNMENT OF ALL MY BACK TEETH. THEY ARE TWISTED AND TILTED AND I CAN NO LONGER CHEW PROPERLY. I SPENT THOUSANDS OF DOLLARS ON SMILE DIRECT BECAUSE I WAS SELF CONSCIOUS OF MY SMILE AND THE COMPANY OFFERED A SOLUTION THAT WAS CHEAPER THAN OTHER OPTIONS. MY DENTIST IS FEARFUL THAT I WILL HAVE SERIOUS ISSUES FOR THE REST OF MY LIFE BECAUSE MY JAW AND TEETH ARE NO LONGER ALIGNED PROPERLY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119034 SMILE DIRECT ALIGNERS ALIGNER, SEQUENTIAL NXC ALIGN TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR