BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANYONE DENTAL IMPLANT SYSTEM

    MDR report key: 10739877 · Received October 26, 2020

    Report

    Report Number
    MW5097453
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    November 26, 2018
    Report Date
    October 22, 2020
    Manufacturer
    MEGAGEN IMPLANT CO. LTD
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    CATASTROPHIC VERTICAL FRACTURE OF IMPLANT HEAD, AT ITS WEAKEST POINT ¿ THE APEX OF INTERNAL HEX CONNECTION- AFTER BEING IN FUNCTION FOR A SHORT DURATION. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203046 ANYONE DENTAL IMPLANT SYSTEM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE MEGAGEN IMPLANT CO. LTD ANYONE 3.5 150624A0312-01

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other| R| S