BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM REG IMPLANT

    MDR report key: 8831165 · Received July 26, 2019

    Report

    Report Number
    8020776-2019-00871
    Event Type
    Injury
    Date Received
    July 26, 2019
    Date of Event
    September 15, 2018
    Report Date
    July 26, 2019
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394000130
    PMA / PMN Number
    K101913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT LATE DUE TO ASR TO INDIVIDUAL REPORTING TRANSITION. NB: REVOCATION OF EXEMPTION (ASR): E2018010. ACCORDING TO THE PRACTITIONER THE IMPLANT DIDN'T TAKE AND FAILED TO INTEGRATE. THE IMPLANT HAS BEEN PLACED IN 36 POSITION ON (B)(6) 2018. 25 DAYS LATER AFTER THE IMPLANTATION, THE PRACTITIONER HAS FOUND THAT THE IMPLANT FAILED TO INTEGRATE. THE IMPLANT HAS FOLLOWED THE COMPLETE MANUFACTURING CYCLE, HAS BEEN VERIFIED AT EACH STAGE OF PRODUCTION, AND HAS BEEN SUBMITTED TO A FINAL RELEASE BEFORE PROVISION OF THE DEVICE ON THE MARKET, WHICH ULTIMATELY GUARANTEES ITS CONFORMITY. THE IMPLANT HAS BEEN EVALUATED THROUGH A BIOLOGICAL RISK ASSESSMENT WHICH CONCLUDES THAT ITS TOXICOLOGICAL PROFILE IS ACCEPTABLE. THE IMPLANT LOSS SUGGESTS THAT THE SOURCE OF THE PROBLEM WAS LIKELY TO COME FROM PROCEDURAL ERRORS AND/OR THE LACK OF OSSEOINTEGRATION. ADDITIONALLY, OTHER FACTORS THAT MAY HAVE CONTRIBUTED TO THE IMPLANT FAILURE INCLUDE BONE CONDITION, PATIENT ORAL HYGIENE, OR PATIENT BEHAVIOR.

    Description of Event or Problem · 1

    IMPLANT FAILS TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627768 AXIOM REG IMPLANT IMPLANT AXIOM D. 4.0 X 10.0 DZE ANTHOGYR OP40100 18-226791 03663394000130

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR