BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE DAY ALIGNERS

    MDR report key: 20737927 · Received November 20, 2024

    Report

    Report Number
    3014845255-2024-02670
    Event Type
    Injury
    Date Received
    November 20, 2024
    Report Date
    October 28, 2025
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    NXC
    UDI-DI
    00850017524163
    PMA / PMN Number
    K230199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803.

    Description of Event or Problem · 0

    PATIENT REPORTED THEY HAD A REALLY BAD PAIN AND WENT TO SEE THEIR DENTIST AND FOUND OUT THEY HAD A CROWN THAT HAS FALLEN OUT. THE CROWN WAS INPLACE WHEN THE PATIENT DID THE IMPRESSION FOR THE ALIGNERS AND THE ALIGNERS DO NOT FIT SINCE THE CROWN HAS FALLEN OUT. THE PATIENT NEEDS TO HAVE THE TOOTH/CROWN REPAIRED, THEY ARE IN TERRIBLE PAIN. PATIENT PROVIDED LETTER OF RECOMMENDATION. THE LETTER STATES, PATIENT PRESENTED WITH LOSS OF #30 CROWN AND CORE BUILDUP. PATIENT HAD CROWN AND CORE ONE MONTH EARLIER AND NOW REQUIRES NEW CROWN AND CORE BUILDUP DUT TO COLD/HOT SENSITIVITY. IF CROWN IS DELAYED, PATIENT MAY LOSE MORE TOOTH STRUCTURE. THIS TREATMETN CANNOT BE DELAYED AND THE ALIGNERS MUST FIT PROPERLY TO PREVENT THIS PROBLEM IN THE FUTURE. A LETTER OF RECOMMENDATION WAS ALSO PROVIDED FROM THE PATIENT'S ORTHODONTIST. IT STATES, 4 WEEKS INTO ALIGNER TREATMENT WITH BYTE, L2-2 HAS SIGNIFICANT MOBILITY. LR1 EXCESSIVE MOBILITY. ROOTS OF L2-2 ARE BLUNTED AND SHORT. U2-2 ROOTS ARE BLUNTED AS WELL. ADVISED PATIENT TO PAUSE TREATMENT IMMEDIATELY TO REMOVE ALL ACTIVE FORCES ON TEETH. PATIENT SHOULD CONTACT LICENSED ORTHODONTIST THAT IS MANAGING PATIENT'S CASE AT BYTE AND SEND THEM CURRENT PANO. EXPLAINED THAT IF PATIENT DOES TREATMENT, IT SHOULD BE DONE VERY SLOWLY WITH SERIAL RADIOGRAPHS OF ROOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2447125 BYTE DAY ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC HBYTE TRAY 00850017524163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability