BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM REG IMPLANT

    MDR report key: 6063786 · Received October 28, 2016

    Report

    Report Number
    8020776-2016-00017
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    September 27, 2016
    Report Date
    October 28, 2016
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394000079
    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 DIDN'T TAKE AND FAILED TO INTEGRATE. THE IMPLANT HAS BEEN PLACED ON (B)(6) 2016. THREE MONTHS LATER AFTER THE IMPLANTATION THE PRACTITIONER HAS FOUND THAT THE IMPLANT FAILED TO INTEGRATE. (B)(4) REVIEWED AND REPORTED FURTHER TO OUR FDA INSPECTION THAT TOOK PLACE FROM (B)(6) 2016.

    Description of Event or Problem · 1

    IMPLANT FAILS TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714960 AXIOM REG IMPLANT IMPLANT AXIOM D3.4 X 12.0 DZE ANTHOGYR OP34120 16-099077 03663394000079

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR