BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGGA

    MDR report key: 17834276 · Received September 27, 2023

    Report

    Report Number
    MW5146230
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    June 1, 2023
    Report Date
    September 25, 2023
    Manufacturer
    UNKNOWN
    Product Code
    JEP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ANTERIOR GROWTH GUIDANCE APPLIANCE AND COMPOSITE ATTACHMENT BURS RESULTED IN FLARED TEETH FOR DAUGHTER, UNEVEN BITE, TEMPOROMANDIBULAR JOINT DISORDER SYMPTOMS OF POPPING AND CLICKING OF JAW JOINT. ANTERIOR GROWTH GUIDANCE APPLIANCE AND COMPOSITE ATTACHMENT BURS FOR SECOND PATIENT RESULTED IN FLARED TEETH, UNEVEN BITE, ROOT LOSS AND LOOSE TEETH. REFERENCE REPORTS MW5146228, MW5146229, MW5146231.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002804 AGGA RETAINER, MATRIX JEP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other