BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIGNERS

    MDR report key: 9335054 · Received November 15, 2019

    Report

    Report Number
    MW5091130
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Date of Event
    August 14, 2019
    Report Date
    November 14, 2019
    Manufacturer
    SMILEDIRECTCLUB / ALIGN TECHNOLOGY INC.
    Product Code
    NXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SIX MONTH ALIGNER TREATMENT - NOTICED THE REQUESTED TREATMENT (GAP CLOSING) WAS NOT BEING MET. I EXPRESSED MY CONCERNS AND WAS APPROVED AND SCHEDULED FOR A REEVALUATION. RECEIVED AN EMAIL WITH AN UPDATED 3D SCAN OF AN ADD'L 2 MONTH TREATMENT PLAN YET THIS PLAN DID NOT ADDRESS CONCERNS NOR WAS INFORMATION GIVEN TO ME ON WHY UNTIL I REQUESTED AN EXPLANATION. IT IS THEN THAT I WAS TOLD THE SPACING CREATED BY THE TREATMENT COULD NOT BE ADDRESSED DUE TO ALIGNER TREATMENT NOT SUPPORTING IT. I WAS THEN TOLD TO GO TO THE DENTIST FOR VENEERS OR BONDING AFTER TRUSTING THEIR PROFESSIONAL "EXPERTISE" AND PAYING FOR A TREATMENT THAT CAUSED ISSUES THAT COULD NOT BE ADDRESSED. THE EXPLANATION WAS THAT THE TREATMENT THAT WAS PROVIDED WAS WHAT WAS PREDICTED. THE SCAN "SHOWS" THE SPACING YET I WAS ALSO TOLD THAT THE 3D SCAN CAN SHOW INACCURATE PROGRESSION DUE TO MULTIPLE FACTORS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120430 ALIGNERS ALIGNER SEQUENTIAL NXC SMILEDIRECTCLUB / ALIGN TECHNOLOGY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR