BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILE DIRECT CLUB INVISIBLE ALIGNERS

    MDR report key: 8615523 · Received May 15, 2019

    Report

    Report Number
    MW5086666
    Event Type
    Injury
    Date Received
    May 15, 2019
    Date of Event
    October 22, 2018
    Report Date
    May 14, 2019
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DUE TO THE UNSUPERVISED NATURE OF SMILE CLUB, MY PT DEVELOPED WORSENING TEMPOROMANDIBULAR JOINT DYSFUNCTION. SHE CAME TO ME STATING SHE CANNOT WEAR HER TRAYS ANYMORE DUE TO MUSCLE SPASMS AND JAW PAIN. INTERVENTION WAS NEEDED AND WE MADE HER A MOUTH GUARD. IN ADDITION, SHE WAS NOT SEEN BY A DENTIST PRIOR TO STARTING SDC, AND WHEN I SAW HER FOUR MONTHS INTO HER TREATMENT, SHE HAD RAMPANT DECAY. THE PT REFUSED TO GET TREATMENT BECAUSE THEN HER "TRAYS WON'T FIT." SDC IS MARKETING TOWARDS MILLENNIALS WHO WANT CHEAPER ALTERNATIVE AND HAVE ISSUES WITH ACCESS TO CARE. THE PROBLEM WITH THIS IS THAT THE AVERAGE PT DOES NOT SEEK THE CARE OF A DENTIST DURING THE ALIGNER THERAPY AND ENDS UP WITH WORSE PROBLEMS THAN WHAT THEY STARTED WITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403989 SMILE DIRECT CLUB INVISIBLE ALIGNERS ALIGNER, SEQUENTIAL NXC ALIGN TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention| S