BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMILE DIRECT CLUB ALIGNERS

    MDR report key: 13846183 · Received March 21, 2022

    Report

    Report Number
    MW5108359
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    February 12, 2022
    Report Date
    March 17, 2022
    Manufacturer
    SMILE DIRECT, LLC./ ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I SIGNED UP TO USE SMILE DIRECT CLUB'S RETAINERS TO STRAIGHTEN MY TEETH. THE RETAINERS WERE OF SUCH POOR QUALITY THAT THEY NEVER DID THE JOB AND THE LAST SET I RECEIVED WOULDN'T EVEN STAY IN MY MOUTH. AT NO POINT IN THE PROCESS WAS A I GIVEN THE OPPORTUNITY TO SPEAK TO A. DENTIST ABOUT MY CONCERNS AND, AFTER EMAILING THEM REPEATEDLY, THEY HAVE STOPPED RESPONDING TO ME ALTOGETHER AND HAVE NOT DONE A THING TO RESOLVE THE PROBLEM. THERE IS NO WAY THIS COMPANY SHOULD BE ALLOWED TO SELL THIS PRODUCT IN THE UNITED STATES. THEY ARE NOT USING PROPER DISCERNMENT IN WHO THEY ARE DOING BUSINESS WITH WHEN IT'S CLEAR THEIR PRODUCT ISN'T GOING TO BE EFFECTIVE. THEIR CUSTOMER SERVICE PEOPLE ARE NOT DENTISTS AND THEY SHOULD NOT BE SERVING AS GO-BETWEENS, BECAUSE THE NUMBER OF PROBLEMS I'VE HAD OVER THE YEARS ARE CLEARLY NOT BEING RELAYED BACK TO A DENTIST. I CAN'T IMAGINE ANY DENTIST WHO IS SERIOUS ABOUT THEIR WORK WOULD PERMIT PEOPLE TO WASTE YEARS USING A PRODUCT THAT THEY CAN CLEARLY SEE ISN'T HAVING AN IMPACT ON THEIR TEETH. THIS ENTIRE PROCESS HAS BEEN AN UNETHICAL FAILURE. FDA SAFETY REPORT ID#:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134743 SMILE DIRECT CLUB ALIGNERS ALIGNER, SEQUENTIAL NXC SMILE DIRECT, LLC./ ALIGN TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male