BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILE DIRECT CLUB ALIGNERS

    MDR report key: 11453448 · Received March 9, 2021

    Report

    Report Number
    MW5099891
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    March 6, 2021
    Report Date
    March 6, 2021
    Manufacturer
    SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I STARTED USING SMILE DIRECT CLUB'S ALIGNERS ON (B)(6) 2019. THEY CONTINUOUSLY HAVE TO RE-SCAN MY TEETH AND SEND MORE ALIGNERS. THESE ALIGNERS LITERALLY DO NOT WORK - THEY HAVE NOT MOVED MY TEETH AT ALL. THESE ARE MEDICAL DEVICES AND I HAVEN'T SEEN OR SPOKEN TO A DENTIST OR ORTHODONTIST OVER THERE AT ALL. THE ONLY PEOPLE WHO WILL TALK TO ME ARE SALES. THIS COMPANY NEEDS TO BE SHUTDOWN. THEY ARE SELLING A MEDICAL DEVICE WITHOUT THE PATIENT SEEING A REAL MEDICAL PROFESSIONAL AND ITS CAUSING HARM IN MULTIPLE WAYS. HOW IN THE WORLD ARE THEY ALLOWED TO CONTINUE THIS?. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345978 SMILE DIRECT CLUB ALIGNERS ALIGNER, SEQUENTIAL NXC SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other