BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILE DIRECT CLUB

    MDR report key: 9559130 · Received January 6, 2020

    Report

    Report Number
    MW5092064
    Event Type
    Injury
    Date Received
    January 6, 2020
    Date of Event
    October 1, 2019
    Report Date
    October 3, 2020
    Manufacturer
    SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT COMPLETED ORTHODONTIC TREATMENT USING SMILE DIRECT CLUB WITHOUT SUPERVISION OF LICENSED DENTIST. PT IS DIAGNOSED WITH GENERALIZED CHRONIC MODERATE TO SEVERE PERIODONTAL DISEASE. PT IS NOT A GOOD CANDIDATE FOR ORTHODONTIC TREATMENT DUE TO GROSS CARIES AND MODERATE TO SEVERE PERIODONTAL DISEASE BUT COMPLETED ORTHODONTIC TREATMENT WITH THE COMPANY KNOWN AS SMILE DIRECT CLUB. PT SHOULD HAVE BEEN REFERRED TO DENTIST TO COMPLETE NEEDED TREATMENT BEFORE ORTHODONTIC WAS STARTED AND COMPLETED. PT IS NOW CONCERNED ABOUT LOOSE TEETH ON THE LOWER ANTERIOR TEETH #23-26. RADIOGRAPHS INDICATED SEVERE BONE LOSS AROUND TEETH #22-26 WITH GENERALIZED SEVERE CALCULUS PRESENT. COMPLETING ORTHODONTIC TREATMENT UNDER THESE ORAL CONDITIONS HAS ADVERSE EFFECTS ON TEETH AND SUPPORTING PERIODONTAL TISSUES. PT WILL NOW HAVE TO HAVE TEETH #23-26 EXTRACTED SOMETIME IN THE NEAR FUTURE. PTS SHOULD HAVE A FULL EXAM COMPLETED INCLUDING RADIOGRAPHS AND BE MONITORED BY A LICENSED DENTIST DURING ANY ORTHODONTIC TREATMENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12529 SMILE DIRECT CLUB ALIGNER, SEQUENTIAL NXC SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention