BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM REG IMPLANT

    MDR report key: 6192403 · Received December 21, 2016

    Report

    Report Number
    8020776-2016-00056
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    October 4, 2016
    Report Date
    December 20, 2016
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394000062
    PMA / PMN Number
    K101913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PRACTITIONER THE IMPLANT IS LOST (LOSS OF OSTEOINTEGRATION) AFTER IMPLANT HAS BEEN RESTORED.THE IMPLANT HAS BEEN PLACED IN 44 POSITION ON (B)(6) 2016 AND REMOVED ON (B)(6) 2016.THE PRACTITIONER REPORTED THAT HIS PATIENT IS A SMOKER.

    Description of Event or Problem · 1

    IMPLANT IS LOST (LOSS OF OSTEOINTEGRATION) AFTER IMPLANT HAS BEEN RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842856 AXIOM REG IMPLANT IMPLANT AXIOM D. 3.4 X 8.0 DZE ANTHOGYR OP34080 11-247514 03663394000062

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR