BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTERIOR GROWTH GUIDANCE APPLIANCE

    MDR report key: 16584296 · Received March 20, 2023

    Report

    Report Number
    MW5115887
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    January 2, 2023
    Report Date
    March 16, 2023
    Manufacturer
    UNKNOWN
    Product Code
    JEP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ANTERIOR GROWTH GUIDANCE APPLIANCE WAS USED ON MY DAUGHTER WHEN SHE WAS YOUNGER. HER TEETH WERE DESTROYED. BECAME CROOKED AND NOT STRONG. HER TEETH BROKE UP EARLY IN LIFE AND HAVE ALWAYS BEEN WEAK. SHE NOW NEEDS IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24440 ANTERIOR GROWTH GUIDANCE APPLIANCE RETAINER, MATRIX JEP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention