BEUDAMED
    FDA Adverse Event Injury Summary report: N

    "AGGA", FAGGA, OSSEO-RESTORE APPLIANCE, ARA

    MDR report key: 16504146 · Received March 7, 2023

    Report

    Report Number
    MW5115541
    Event Type
    Injury
    Date Received
    March 7, 2023
    Date of Event
    February 12, 2020
    Report Date
    March 3, 2023
    Manufacturer
    JOHNS DENTAL LABORATORIES
    Product Code
    JEP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USE OF AN "AGGA" APPLIANCE THAT CLAIMED TO GROW ADULT JAWS FORWARD. SIGNIFICANT BONE LOSS, TISSUE DAMAGE, TMD, TOOTH LOSS (B)(6) PRODUCT WAS NEVER REGISTERED WITH THE FDA. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715914 "AGGA", FAGGA, OSSEO-RESTORE APPLIANCE, ARA RETAINER, MATRIX JEP JOHNS DENTAL LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other| S