BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM REG IMPLANT

    MDR report key: 7690510 · Received July 16, 2018

    Report

    Report Number
    8020776-2018-01052
    Event Type
    Injury
    Date Received
    July 16, 2018
    Date of Event
    April 13, 2018
    Report Date
    July 13, 2018
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394000130
    PMA / PMN Number
    K101913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTATION IS CONSECUTIVE TO THE RUPTURE OF A PROSTHETIC SCREW INSIDE THE IMPLANT. AFTER ASKING THE PRACTITIONER IT HAS BEEN DISCOVERED THAT THE ABUTMENT (ABUTMENT NOT RETURNED) WAS CUSTOM MADE, AND THE PROSTHETIC SCREW WAS NOT MANUFACTURED BY ANTHOGYR. GIVEN THESE ELEMENTS, IT IS DIFFICULT TO GO FURTHER IN OUR ANALYSIS.

    Description of Event or Problem · 1

    A FRAGMENT OF SCREW WAS BLOCKED INSIDE THE IMPLANT. THE PRACTITIONER TRIED TO USE A SCREW EXTRACTION KIT TO REMOVE THE BROKEN SCREW FRAGMENT INSIDE THE IMPLANT THE (B)(6) 2018. DESPITE THE HELP OF A PROSTHESIS EXPERT, HE FAILED TO EXTRACT THE FRAGMENT OF SCREW. THAT IS WHY, ULTIMATELY THE PRACTITIONER DECIDED TO REMOVE THE IMPLANT THE (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533030 AXIOM REG IMPLANT IMPLANT AXIOM D. 4.0 X 12.0 DZE ANTHOGYR OP40120 15-043566 03663394000130

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR