BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BYTE DAY ALIGNER

    MDR report key: 20531946 · Received October 25, 2024

    Report

    Report Number
    3014845255-2024-02262
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Report Date
    October 20, 2025
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    NXC
    UDI-DI
    00850017524163
    PMA / PMN Number
    K230199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803.

    Additional Manufacturer Narrative · 0

    A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 0

    PATIENT REPORTED THE UPPER ALIGNER IS CUTTING INTO THEIR CHEEK AND IT IS UNCOMFORTABLE. PROVIDED HHTT TIPS AND FOR REQUESTED PATIENT TO TRY ON NEXT STEP ALIGNER AND PROVIDE PHOTO FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026021 BYTE DAY ALIGNER ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC HBYTE TRAY 00850017524163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown