BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMILEDIRECT

    MDR report key: 8620024 · Received May 16, 2019

    Report

    Report Number
    MW5086710
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 16, 2019
    Report Date
    May 14, 2019
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PT IS IN THE MIDDLE OF SMILEDIRECTS AT HOME TREATMENT. TOOTH #26 HAS BEEN PUSHED COMPLETELY LINGUAL AND WILL EVENTUALLY NEED FURTHER TREATMENT. PT SAID THAT SMILEDIRECTS PLAN WAS JUST TO PUSH THIS TOOTH BACK AND LEAVE IT LIKE IT IS. DO YOU HAVE A PICTURE OF THE PRODUCT? YES. START: (B)(6) 2018. IS THERAPY STILL ONGOING? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407718 SMILEDIRECT ALIGNER, SEQUENTIAL NXC ALIGN TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR