BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL CLEAR ALIGNERS

    MDR report key: 17852343 · Received October 2, 2023

    Report

    Report Number
    2081322-2023-00004
    Event Type
    Injury
    Date Received
    October 2, 2023
    Date of Event
    July 19, 2023
    Report Date
    October 2, 2023
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    NXC
    UDI-DI
    00190707096946
    PMA / PMN Number
    K210613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    PATIENT REPORTED HE TRIED TO WEAR THE STEP 1 MAXILLARY TRAY FOR 2-3 DAYS, BUT DISCONTINUED BECAUSE OF JAW PAIN DESPITE TAKING IBUPROFEN. HE WAS ABLE TO TOLERATE THE LOWER TRAY. ACCORDING TO THE DOCTOR'S OFFICE, THEY INITIALLY INSTRUCTED THE PATIENT NOT TO BITE THE TRAYS IN AT INSERTION. THE PATIENT THOUGHT HE SHOULD NOT BE BITING AT ALL WHILE WEARING THE ALIGNERS, SO HE KEPT OPENING HIS MOUTH. ACCORDING TO THE DOCTOR'S OFFICE, THIS COULD HAVE CONTRIBUTED TO TMJ PAIN. HE TRIED TO WEAR THE TRAYS AGAIN, BUT COULDN'T BECAUSE OF SORENESS AROUND HIS TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977075 REVEAL CLEAR ALIGNERS SEQUENTIAL ALIGNERS NXC ORTHO ORGANIZERS, INC. 140-8735 00190707096946

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention