BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE REGULAR RETAINER

    MDR report key: 20729336 · Received November 19, 2024

    Report

    Report Number
    3014845255-2023-01807
    Event Type
    Injury
    Date Received
    November 19, 2024
    Report Date
    November 18, 2024
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    KMY
    UDI-DI
    00850017524187
    PMA / PMN Number
    K180346
    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 21CFR PART 803. THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS AND HARMONIZATION MADE TO THE COMPANY'S COMPLAINT HANDLING PROCESSES. THERE IS NO CHANGE TO DEVICE PERFORMANCE OR TO THE DEVICE RISK PROFILE. A CAPA (2023-487) HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. THIS RETROSPECTIVE REVIEW INCLUDES THE DATE RANGE OF 05/17/2021 THROUGH 05/31/2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE REGULAR RETAINER, THE PATIENT'S LOCAL DENTIST FOUND #8 TOOTH WAS LOOSE AND THE RETAINER (RET) WERE A BIT LOOSE AND THE PATIENT EXPERIENCED A BIT OF DISCOMFORT ON HER JAW/TEETH AFTER REMOVING THE RETS ON THE MORNING. ADDITIONAL INFORMATION: LETTER OF RECOMMENDATION (LOR) FROM DOCTOR OF DENTAL SURGERY (DDS) STATING THE CUST NEEDS A NEW RET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2307453 BYTE REGULAR RETAINER POSITIONER, TOOTH, PREFORMED KMY STRAIGHT SMILE, LLC NBYTE TRAY NA 00850017524187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown