BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE RETAINER

    MDR report key: 20306775 · Received September 25, 2024

    Report

    Report Number
    3014845255-2024-01226
    Event Type
    Injury
    Date Received
    September 25, 2024
    Report Date
    November 9, 2025
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    KMY
    UDI-DI
    00850017524187
    Adverse Event
    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 THEY WERE SEEN AT THEIR DENTIST WHICH FOUND THE GUM RECEDING AND RED AROUND A TOOTH. THEIR DENTIST THINKS IT COULD BE THAT THE TOOTH IS TALLER THAN THE OTHERS AND WHEN THEY BITE, IT PUTS PRESSURE ON THAT TOOTH. THE DENTIST WANTS TO SHAVE IT DOWN TO THE SAME HEIGHT AS THE OTHER TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291890 BYTE RETAINER POSITIONER, TOOTH, PREFORMED KMY STRAIGHT SMILE, LLC BYTERETAINER 00850017524187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention