BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM REG IMPLANT

    MDR report key: 6184695 · Received December 19, 2016

    Report

    Report Number
    8020776-2016-00042
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 28, 2016
    Report Date
    December 16, 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 DIDN'T TAKE AND FAILED TO INTEGRATE. THE IMPLANT HAS BEEN PLACED IN 47 POSITION ON (B)(6) 2016. TWO MONTHS LATER AFTER THE IMPLANTATION, THE PRACTITIONER HAS FOUND THAT THE IMPLANT FAILED TO INTEGRATE. ALSO, THE PRACTITIONER REPORTED THAT HIS PATIENT IS A SMOKER.

    Description of Event or Problem · 1

    IMPLANT FAILS TO OSTEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837664 AXIOM REG IMPLANT IMPLANT AXIOM D. 4.0 X 10.0 DZE ANTHOGYR OP40100 16-104169 03663394000130

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR