BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARRIERE SLX 3D

    MDR report key: 13550087 · Received February 17, 2022

    Report

    Report Number
    2081322-2022-00001
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Report Date
    February 17, 2022
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    EJF
    UDI-DI
    00190707048402
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER A ROUND OF ROUTINE POST-MARKET BIOCOMPATIBILITY STUDIES, ORTHO ORGANIZERS BECAME AWARE THAT A SAMPLE OF SLX 3D ORTHODONTIC BRACKETS HAD FAILED CYTOTOXICITY TESTING. THE ORGANIZATION IS CURRENTLY CONDUCTING AN INVESTIGATION UNDER AN INTERNAL CAPA.

    Description of Event or Problem · 0

    AFTER A ROUND OF ROUTINE POST-MARKET BIOCOMPATIBILITY STUDIES, ORTHO ORGANIZERS BECAME AWARE THAT A SAMPLE OF SLX 3D ORTHODONTIC BRACKETS HAD FAILED CYTOTOXICITY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864393 CARRIERE SLX 3D ORTHODONTIC METAL BRACKET EJF ORTHO ORGANIZERS, INC. 777-UR1-10 00190707048402

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other