BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM REG IMPLANT

    MDR report key: 7129524 · Received December 19, 2017

    Report

    Report Number
    8020776-2017-01188
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    October 17, 2017
    Report Date
    December 18, 2017
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394000246
    PMA / PMN Number
    K101913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE BREAKAGE OF THE PROSTHESIS WAS NOT CAUSED BY THE ANTHOGYR IMPLANT. THE IMPLANT WAS CONSISTENT AND WELL OSTEO-INTEGRATED. IT HAS BEEN PLACED IN 26 POSITION ON (B)(6) 2015 AND HAS BEEN EXPLANTED ON (B)(6) 2017. WE HAVE RECEIVED CONFIRMATION THAT THE IMPLANT WAS AN ANTHOGYR PRODUCT ON (B)(6) 2017 BY EMAIL FROM THE PRACTIONER. THE OUTCOME OF EXTRACTION OF THE IMPLANT IS RELATED TO THE FAILURE TO REMOVE THE BROKEN ABUTMENT PART IN IT. SINCE, THE AXIOM® ABUTMENT EXTRACTOR SET HAS EVOLVED AND IMPROVES THE CHANCES OF SUCCESSFUL REMOVAL OF BROKEN ELEMENTS IN AN IMPLANT.

    Description of Event or Problem · 1

    IMPLANT HAS BEEN EXPLANTED BY THE PRACTITIONER BECAUSE ATTEMPT TO REMOVE THE BROKEN PART OF AN ABUTMENT FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910939 AXIOM REG IMPLANT IMPLANT AXIOM D.5.2 X 8.0 DZE ANTHOGYR OP52080 14-024350 03663394000246

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR