BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM REG IMPLANT

    MDR report key: 9295502 · Received November 8, 2019

    Report

    Report Number
    8020776-2019-02472
    Event Type
    Injury
    Date Received
    November 8, 2019
    Date of Event
    June 11, 2019
    Report Date
    November 8, 2019
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394000246
    PMA / PMN Number
    K101913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE BASE OF THE ABUTMENT HAS BROKEN AND DAMAGED THE IMPLANT. ULTIMATELY THE PRACTITIONER DECIDED TO REMOVE THE IMPLANT. THE BREAKAGE OF THE PROSTHESIS WAS NOT CAUSED BY THE ANTHOGYR IMPLANT. BREAKAGE MAY BE THE RESULT OF EXCESSIVE FORCE EXERTED ON THE PROTHESIS.

    Description of Event or Problem · 1

    A FRAGMENT OF THE ABUTMENT REMAINED BLOCKED INSIDE THE IMPLANT. THE PRACTITIONER TRIED TO REMOVE THE FRAGMENT OF THE ABUTMENT BUT HE FAILED. THAT IS WHY, ULTIMATELY, THE PRACTITIONER DECIDED TO REMOVE THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090209 AXIOM REG IMPLANT IMPLANT AXIOM D. 5.2 X 8.0 DZE ANTHOGYR OP52080 16-118604 03663394000246

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR