BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT

    MDR report key: 11831848 · Received May 14, 2021

    Report

    Report Number
    MW5101381
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    October 22, 2020
    Report Date
    May 13, 2021
    Manufacturer
    MEGAGEN IMPLANT CO., LTD.
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD AN IMPLANT PLACED AND THEN A FEW YEARS AFTER THE IMPLANT FRACTURED AND I HAD TO HAVE IT REMOVED. THERE HAS BEEN PROBLEMS WITH THIS SIZE IMPLANT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725675 IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE MEGAGEN IMPLANT CO., LTD. ANYONE 3.5 130708A30-01

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other