BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BYTE RETAINER

    MDR report key: 20275388 · Received September 21, 2024

    Report

    Report Number
    3014845255-2024-01137
    Event Type
    Malfunction
    Date Received
    September 21, 2024
    Report Date
    October 14, 2025
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    KMY
    UDI-DI
    00850017524187
    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 RETAINERS, PATIENT REPORTED THAT THEIR RETAINER BROKE AND CUT THEIR LIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496983 BYTE RETAINER POSITIONER, TOOTH, PREFORMED KMY STRAIGHT SMILE, LLC BYTERETAINER 00850017524187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention