BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FXTETRA BRIGHT RETAINER

    MDR report key: 11838786 · Received May 17, 2021

    Report

    Report Number
    3015143007-2021-00001
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 17, 2021
    Manufacturer
    SMYLIO
    Product Code
    DYT
    PMA / PMN Number
    CLASS I
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND ANALYZED. NO ISSUES WERE FOUND WITH THE DEVICE OR IN THE MANUFACTURING PROCESS/RECORDS FOR THE DEVICE. TREND AND RISK ANALYSIS REPORTS WERE PULLED, REVIEWED AND DISCUSSED WITH PROFESSIONAL MEDICAL PERSONNEL (DENTISTS) TO ASSESS THE CASE. THE CONCLUSION WAS THAT THE PATIENT'S PREVIOUS DENTAL RESTORATION WORK WAS IN POOR SHAPE. THIS DENTAL WORK WAS NOT ASSOCIATED OR RELATED TO THE PRODUCT AT ALL. THIS POOR DENTAL WORK WAS DETERMINED TO BE THE ROOT CAUSE OF THE EVENT. THE DEVICE PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT A SMALL CHIP OF HER TOOTH CAME OUT WHEN REMOVING THE DENTAL RETAINER AT NIGHT. SHE RETURNED THE PRODUCT FOR EVALUATION. THE CUSTOMER SERVICE TEAM ADVISED HER TO SEEK A DENTAL PROFESSIONAL FOR HELP WITH HER TOOTH. THE PATIENT THEN STOP RESPONDING TO OUR EMAILS AND CALLS. WE HAVE TRIED 3 OR MORE TIMES TO CONTACT HER TO SO WE CAN UNDERSTAND ANY RESOLUTION TO THIS CASE. WE HAVE NO RESPONSES AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729896 FXTETRA BRIGHT RETAINER DENTAL RETAINER DYT SMYLIO SMY-009

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention