BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM REG IMPLANT

    MDR report key: 9289238 · Received November 7, 2019

    Report

    Report Number
    8020776-2019-02437
    Event Type
    Injury
    Date Received
    November 7, 2019
    Date of Event
    October 4, 2019
    Report Date
    November 4, 2019
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394000208
    PMA / PMN Number
    K101913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT HAS BEEN PLACED IN 36 POSITION ON (B)(6) 2017 AND HAS BEEN EXPLANTED ON (B)(6) 2019. FOLLOWING ABUTMENT BREAK, A FRAGMENT OF THE ABUTMENT REMAINED BLOCKED INSIDE THE IMPLANT. THE PRACTITIONER TRIED TO USE A RESCUE KIT BUT HE FAILED TO REMOVE THE FRAGMENT OF THE ABUTMENT BECAUSE HE BROKE THE TAPPER INSIDE. THAT IS WHY, ULTIMATELY, THE PRACTITIONER DECIDE 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 PROSTHESIS. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087290 AXIOM REG IMPLANT IMPLANT AXIOM D 4.6 X 10.0 DZE ANTHOGYR OP46100 17-190674 03663394000208

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR