BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM REG IMPLANT

    MDR report key: 6180264 · Received December 16, 2016

    Report

    Report Number
    8020776-2016-00038
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    October 10, 2016
    Report Date
    December 13, 2016
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394000130
    PMA / PMN Number
    K101913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PRACTITIONER THE IMPLANT IS LOST (LOSS OF OSSEOINTEGRATION) AFTER IMPLANT HAS BEEN RESTORED. THE IMPLANT HAS BEEN PLACED IN 45 POSITION ON (B)(6) 2014 AND REMOVED ON (B)(6) 2016.

    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
    831667 AXIOM REG IMPLANT IMPLANT AXIOM D. 4.0 X 10.0 DZE ANTHOGYR OP40100 13-004191 03663394000130

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR