BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM PX IMPLANT

    MDR report key: 8054208 · Received November 9, 2018

    Report

    Report Number
    8020776-2018-01384
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    June 19, 2018
    Report Date
    October 24, 2018
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394000147
    PMA / PMN Number
    K161177
    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, FIRST OF THE SCREW, SECOND OF THE ABUTMENT, AND THIRDLY OF THE IMPLANT. AFTER ASKING THE PRACTITIONER, THE ABUTMENT AND THE PROSTHETIC SCREW WERE RETURNED TO US. THE IMPLANT AND THE PROSTHETIC SCREW ARE MANUFACTURED BY ANTHOGYR. THE ABUTMENT IS CUSTOM-MADE. THE PATIENT IS A MAN, AND IS (B)(6). HE HAS A MEDIUM BONE DENSITY. ACCORDING TO THE PRACTITIONER, THE PATIENT HAD COME TO HIS OCCLUSION CONTROL ON (B)(6) 2017. THE PRACTITIONER DID SEND US A RADIO BUT IT IS NO SUFFICIENT FOR ANALYSIS. WE ASKED FOR A MORE PRECISE PANORAMIC RADIO, BUT THE PRACTITIONER DOES NOT HAVE ONE. IT IS SO DIFFICULT TO ANALYZE WITH PRECISELY IF THE PROSTHETIC CONSTRUCTION IS NORMAL OR NOT. GIVEN THESE ELEMENTS, IT IS DIFFICULT TO GO FURTHER IN OUR ANALYSIS.

    Description of Event or Problem · 1

    THE PRACTITIONER DECIDED TO REMOVE THE IMPLANT AFTER THE FRACTURE OF THE ABUTMENT AND THE SCREW OF THE PROSTHESIS, AND AFTER THE BREAKAGE OF THE IMPLANT. THE IMPLANT HAS BEEN PLACED IN 23 POSITION ON (B)(6) 2016, AND HAS BEEN EXPLANTED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895114 AXIOM PX IMPLANT IMPLANT AXIOM D. 4.0 X 12.0 DZE ANTHOGYR PX40120 15-070136 03663394000147

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention