BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM REG IMPLANT

    MDR report key: 8825360 · Received July 25, 2019

    Report

    Report Number
    8020776-2019-00750
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    March 2, 2019
    Report Date
    July 24, 2019
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394000055
    PMA / PMN Number
    K101913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 TWO IMPLANTS DIDN'T TAKE AND FAILED TO INTEGRATE. THE IMPLANTS HAVE BEEN PLACED IN 23 POSITION ON (B)(6) 2019. 1 MONTH LATER AFTER THE IMPLANTATION, THE PRACTITIONER HAS FOUND THAT THE IMPLANTS FAILED TO INTEGRATE. THE IMPLANTS HAVE FOLLOWED THE COMPLETE MANUFACTURING CYCLE, HAVE BEEN VERIFIED AT EACH STAGE OF PRODUCTION, AND HAVE BEEN SUBMITTED TO A FINAL RELEASE BEFORE PROVISION OF THE DEVICE ON THE MARKET, WHICH ULTIMATELY GUARANTEES THEIR CONFORMITY. THE IMPLANTS HAVE BEEN EVALUATED THROUGH A BIOLOGICAL RISK ASSESSMENT WHICH CONCLUDES THAT THEIR TOXICOLOGICAL PROFILE IS ACCEPTABLE. THE IMPLANTS 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

    TWO IMPLANTS FAILS TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619300 AXIOM REG IMPLANT IMPLANT AXIOM D. 3.4 X 8.0 DZE ANTHOGYR OP34080 18-250727 03663394000055

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR