BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM REG IMPLANT

    MDR report key: 9436635 · Received December 9, 2019

    Report

    Report Number
    8020776-2019-02604
    Event Type
    Injury
    Date Received
    December 9, 2019
    Date of Event
    April 12, 2018
    Report Date
    November 4, 2019
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394000079
    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) 2018 AND HAS BEEN EXPLANTED ON (B)(6) 2019. FOLLOWING SCREW BREAK, A FRAGMENT OF THE SCREW REMAINED BLOCKED INSIDE THE IMPLANT. THE PRACTITIONER TRIED TO REMOVE THE BROKEN SCREW END OF THE IMPLANT BY HIS OWN MEANS, BUT HE FAILED TO REMOVE THE FRAGMENT OF THE SCREW. THAT IS WHY, ULTIMATELY, THE PRACTITIONER DECIDED TO REMOVE THE IMPLANT. FURTHERMORE, THE ABUTMENT IS POLISHED AND DISTORTED. THE CONNECTION HAS BEEN REWORKED AND THERE IS NO CONE. IT IS NOT USUAL TO USE 3.4 DIAMETER IMPLANTS IN THE POSTERIOR DENTAL AREA. SINCE THIS CONFIGURATION IS NOT VALIDATED BY ANTHOGYR, ANTHOGYR CAN NOT BE HELD RESPONSIBLE FOR THE BREAKAGE OF THE SCREW. (B)(4).

    Description of Event or Problem · 1

    FOLLOWING THE ABUTMENT'S SCREW BREAK, A FRAGMENT OF IT REMAINED BLOCKED INSIDE THE IMPLANT. THE PRACTITIONER TRIED TO REMOVE THE BROKEN SCREW END OF THE IMPLANT BY HIS OWN MEANS BUT HE FAILED TO REMOVE THE FRAGMENT OF THE SCREW. THAT IS WHY, ULTIMATELY, THE PRACTITIONER DECIDED TO REMOVE THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233671 AXIOM REG IMPLANT IMPLANT AXIOM D 3.4 X 12.0 DZE ANTHOGYR OP34120 17-220201 03663394000079

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR