BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM REG IMPLANT

    MDR report key: 7057179 · Received November 23, 2017

    Report

    Report Number
    8020776-2017-01098
    Event Type
    Malfunction
    Date Received
    November 23, 2017
    Date of Event
    August 18, 2017
    Report Date
    November 22, 2017
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394000079
    PMA / PMN Number
    K101913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 IN 11 POSITION ON (B)(6) 2017. EIGHT DAYS LATER AFTER THE IMPLANTATION, THE PRACTITIONER HAS FOUND THAT THE IMPLANT FAILED TO INTEGRATE.

    Description of Event or Problem · 1

    IMPLANT FAILS TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835992 AXIOM REG IMPLANT IMPLANT AXIOM D. 3.4. X 12.0 DZE ANTHOGYR OP34120 17-187851 03663394000079

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR