BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILE DIRECT CLUB

    MDR report key: 9295620 · Received November 7, 2019

    Report

    Report Number
    MW5090977
    Event Type
    Injury
    Date Received
    November 7, 2019
    Report Date
    October 25, 2019
    Manufacturer
    SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    I HAD AN ADULT PATIENT YESTERDAY WHO RECENTLY COMPLETED A COURSE OF TREATMENT AND A REFINEMENT WITH SMILE DIRECT CLUB. HE HAD NO EXAM WITH A DOCTOR OR X- RAYS PRIOR TO HIS ORTHODONTIC TREATMENT. HE HAS PERIODONTALLY COMPROMISED TEETH THAT WERE MOVED WITH NO REGARD FOR THE LONGEVITY OF THE TEETH. HE NOW HAS A TRAUMATIC OCCLUSION ON THESE PERIODONTALLY COMPROMISED TEETH THAT IF UNTREATED WILL RESULT IN THEIR EARLY LOSS. ADDITIONALLY, HE HAS A POSTERIOR OPEN BITE, HAS DIFFICULTY CHEWING AND SHIFTS HIS JAW TO TRY TO FIND A COMFORTABLE BITING POSITION, WHICH MAY LEAD TO TEMPORO-MANDIBULAR DISCOMFORT. THIS IS NOT THE FIRST TIME I SAW A PATIENT UNHAPPY WITH SMILE DIRECT. THIS IS A PRIME EXAMPLE OF MALPRACTICE BY SMILE DIRECT. SMILE DIRECT, CANDID AND OTHER COMPANIES LIKE THIS ARE THREATS TO PUBLIC HEALTH. THEY CURRENTLY DO NOT MEET THE STANDARD OF CARE FOR TREATING PATIENTS ORTHODONTICALLY AND THUS SHOULD NOT BE ALLOWED TO PRACTICE DENTISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088502 SMILE DIRECT CLUB ALIGNER, SEQUENTIAL NXC SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention