BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMILE DIRECT CLUB DENTAL ALIGNERS

    MDR report key: 8605119 · Received May 10, 2019

    Report

    Report Number
    MW5086585
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 30, 2019
    Report Date
    May 8, 2019
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO OUR OFFICE WITH AN ANTERIOR AND POSTERIOR OPEN BITE - THE PT WAS ONLY BITING ON HER R AND L SECOND MOLARS. NO OTHER TEETH WERE IN OCCLUSION. SHE HAD COMPLAINED TO SMILE DIRECT CLUB ABOUT ONLY BEING ABLE TO BITE ON TWO TEETH ON EACH SIDE. THEY REPORTED TO HER THAT THEY COULD NOT FIX HER PROBLEM AND SIMPLY TOLD HER TO "ENJOY HER SMILE." I BELIEVE THE ISSUE COULD HAVE BEEN CORRECTED WITH PROFESSIONAL LEVEL SERVICES. WE WERE ONLY ABLE TO PARTIALLY CORRECT HER ISSUE WITH A BITE ADJUSTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395577 SMILE DIRECT CLUB DENTAL ALIGNERS ALIGNER, SEQUENTIAL NXC ALIGN TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR