BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTERIOR GROWTH GUIDANCE APPLIANCE

    MDR report key: 16743735 · Received April 13, 2023

    Report

    Report Number
    MW5116641
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    March 25, 2023
    Report Date
    April 12, 2023
    Manufacturer
    UNK
    Product Code
    JEP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SLEEP APNEA APPLIANCE CAUSING CLASS III ANTERIOR CROSSBITE AND PROCLINATION OF LOWER ANTERIOR INCISORS WITH GINGIVAL RECESSION AND TRAUMATIC OCCLUSION. MANY DIFFERENT MANUFACTURERS CUSTOM MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103034 ANTERIOR GROWTH GUIDANCE APPLIANCE RETAINER, MATRIX JEP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other