BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM PX IMPLANT

    MDR report key: 9189634 · Received October 15, 2019

    Report

    Report Number
    8020776-2019-02043
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    September 13, 2019
    Report Date
    October 14, 2019
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394002592
    PMA / PMN Number
    K161177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT HAS BEEN PLACED IN 22 POSITION ON 06/22/2017 AND HAS BEEN EXPLANTED ON (B)(6) 2019. BROKEN SCREW INSIDE THE IMPLANT. THE PRACTITIONER TRIED TO USE A RESCUE KIT BUT HE FAILED TO REMOVE THE FRAGMENT OF THE SCREW. THAT IS WHY, ULTIMATELY, THE PRACTITIONER DECIDE TO REMOVE THE IMPLANT. ALL THE PRODUCTS (IMPLANT, SCREW AND ABUTMENT) HAVEN'T BEEN RETURNED TO US. THE BREAKAGE OF THE PROSTHESIS WAS NOT CAUSED BY THE ANTHOGYR IMPLANT. BREAKAGE MAY BE THE RESULT OF EXCESSIVE FORCE EXERTED ON THE PROSTHESIS.

    Description of Event or Problem · 1

    BROKEN SCREW INSIDE THE IMPLANT. THE PRACTITIONER TRIED TO USE A RESCUE KIT BUT HE FAILED TO REMOVE THE FRAGMENT OF THE SCREW. THAT IS WHY, ULTIMATELY, THE PRACTIONER DECIDE TO REMOVE THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987850 AXIOM PX IMPLANT IMPLANT AXIOM D 4.0 X 14.0 DZE ANTHOGYR PX40140 17-166993 03663394002592

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR