BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BYTE RETAINER

    MDR report key: 20248276 · Received September 18, 2024

    Report

    Report Number
    3014845255-2024-01088
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Report Date
    October 9, 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 RETAINERS CUT THE INSIDE BOTTOM OF THEIR MOUTH. THEY HAVE RAZOR SHARP EDGES THAT CAUSED CUTS AND BLISTERS. PATIENT ATTEMPTED WARM WATER TIP AND FILING BUT DID NOT HELP. ADVISED PATIENT TO GO TO MOST COMFORTABLE ALIGNER OR PURCHASE A BOIL AND BITE TO MAINTAIN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302306 BYTE RETAINER POSITIONER, TOOTH, PREFORMED KMY STRAIGHT SMILE, LLC BYTERETAINER 00850017524187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention