BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BYTE NIGHT ALIGNER

    MDR report key: 20186557 · Received September 10, 2024

    Report

    Report Number
    3014845255-2024-00987
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Report Date
    October 4, 2025
    Manufacturer
    STRAIGHT SMILE , LLC
    Product Code
    NXC
    UDI-DI
    00850017524170
    PMA / PMN Number
    K230199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 0

    WHILE USING A BYTE NIGHT ALIGNERS, PATIENT REPORTED THAT THE ALIGNERS CUTTING THEIR CHEEK. ADVISED PATIENT TO FILE ANY SHARP EDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021257 BYTE NIGHT ALIGNER ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE , LLC NBTYE TRAY 00850017524170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention