BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM PX IMPLANT

    MDR report key: 11138954 · Received January 8, 2021

    Report

    Report Number
    8020776-2020-02253
    Event Type
    Injury
    Date Received
    January 8, 2021
    Date of Event
    September 29, 2020
    Report Date
    December 18, 2020
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394002578
    PMA / PMN Number
    K161177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ABUTMENT BROKEN AFTER 4 YEARS IN MOLAR SECTOR (46 POSITION). A FRAGMENT OF THE ABUTMENT WAS BLOCKED INSIDE THE IMPLANT. THE PRACTITIONER TRIED TO USE THE RESCUE KIT, BUT HE FAILED TO REMOVE THE FRAGMENT OF THE ABUTMENT. THE PRACTITIONER, AT THE PATIENT'S REQUEST, DIDN'T REMOVE THE IMPLANT BUT PLAN TO PLACE ANOTHER IMPLANT NEXT TO IT IN POSITION 47. THE BREAKAGE OF THE PROSTHESIS WAS NOT CAUSED BY THE ANTHOGYR IMPLANT. THE IMPLANT WAS CONSISTENT AND WELL OSTEO-INTEGRATED. BREAKAGE MAY BE THE RESULT OF EXCESSIVE FORCE EXERTED ON THE PROSTHESIS WITH AN OVERHANG.

    Description of Event or Problem · 1

    A FRAGMENT OF THE ABUTMENT WAS BLOCKED INSIDE THE IMPLANT. THE PRACTITIONER TRIED TO USE THE RESCUE KIT, BUT HE FAILED TO REMOVE THE FRAGMENT OF THE ABUTMENT. THE PRACTITIONER, AT THE PATIENT'S REQUEST, DIDN'T REMOVE THE IMPLANT BUT PLAN TO PLACE ANOTHER IMPLANT NEXT TO IT IN POSITION 47.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38962 AXIOM PX IMPLANT IMPLANT AXIOM D.4.0 X 10.0 DZE ANTHOGYR PX40100 15-070885 03663394002578

    Patients

    Seq Age Sex Outcome Treatment
    1