BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE RETAINER

    MDR report key: 20344381 · Received October 1, 2024

    Report

    Report Number
    3014845255-2022-00083
    Event Type
    Injury
    Date Received
    October 1, 2024
    Report Date
    December 18, 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 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.

    Additional Manufacturer Narrative · 0

    A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 0

    CUST HAS BEEN WEARING RET FOR 2 WEEKS FULL TIME AND THEY ARE VERY TIGHT, CUST IS HAVING EXTREME PAIN IN THEM. LAST ALIGNERS ARE FITTING WELL AND THEY WILL BE WEARING THOSE IN THE MEANTIME. SENT BE FOR RET IK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44979 BYTE RETAINER POSITIONER, TOOTH, PREFORMED KMY STRAIGHT SMILE, LLC BYTERETAINER NA 00850017524187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention