BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMILE DIRECT CLUB ALIGNERS

    MDR report key: 8981390 · Received September 9, 2019

    Report

    Report Number
    MW5089647
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    June 1, 2019
    Report Date
    September 5, 2019
    Manufacturer
    SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SMILE DIRECT CLUB ADVERTISED THAT THEY COULD FIX A SMALL GAP IN MY MIDDLE TEETH. THEY MADE THE GAP WORSE, AFTER ANOTHER TREATMENT PLAN, THEY SAID AN ORTHODONTIST REVIEWED IT AND APPROVED AN ADD'L PLAN. AFTER A MONTH, IT WAS WORSE. THEY THEN SAID THEY CAN'T FIX IT AND THERE IS NOTHING THEY CAN DO. THEY CLAIM IT'S UNFIXABLE WITH ALIGNERS. THEY TOLD ME THEY COULD FIX IT AND CHARGED ME (B)(6) AND MADE IT WORSE. NOW MY BITE IS BAD WHEN I COULD BITE CORRECTLY BEFORE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772181 SMILE DIRECT CLUB ALIGNERS ALIGNER, SEQUENTIAL NXC SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR