BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM PX IMPLANT

    MDR report key: 8763676 · Received July 5, 2019

    Report

    Report Number
    8020776-2019-00553
    Event Type
    Injury
    Date Received
    July 5, 2019
    Date of Event
    June 6, 2019
    Report Date
    July 5, 2019
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    00036633940025
    PMA / PMN Number
    K161177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT HAS BEEN PLACED IN 22 POSITION ON (B)(6) 2018 AND HAS BEEN EXPLANTED ON (B)(6) 2019. FOLLOWING ABUTMENT BREAK, A FRAGMENT OF THE LOCATOR ABUTMENT REMAINED BLOCKED INSIDE THE IMPLANT. THE PRACTITIONER TRIED TO USE THE RESCUE KIT BUT HE FAILED TO REMOVE THE FRAGMENT OF THE ABUTMENT. THAT IS WHY, ULTIMATELY, THE PRACTITIONER DECIDED TO REMOVE THE IMPLANT. THE ABUTMENT HAS NOT BEEN RETURNED TO US. NO INFORMATION COULD BE RECOVERED TO ANALYZE THE MANUFACTURING PROCESS OF THIS ABUTMENT, AND WE ARE UNABLE TO IDENTIFY THE PILLAR'S PART NUMBER. THE PRACTITIONER DOESN'T HAVE THE TRACEABILITY OF THIS ABUTMENT. ANOTHER IMPLANT FROM THE SAME PATIENT HAS BEEN EXPLANTED THE SAME DAY. SEE MFR REPORT 8020776-2019-00554 FOR MORE DETAILS (COMPLAINT NUMBER : (B)(4)).

    Description of Event or Problem · 1

    FOLLOWING LOCATOR ABUTMENT BREAK, A FRAGMENT OF THE ABUTMENT REMAINED BLOCKED INSIDE THE IMPLANT. THE PRACTITIONER TRIED TO USE THE RESCUE KIT BUT HE FAILED TO REMOVE THE FRAGMENT OF THE ABUTMENT. THAT IS WHY, ULTIMATELY, THE PRACTITIONER DECIDED TO REMOVE THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557182 AXIOM PX IMPLANT IMPLANT AXIOM D. 3.4 X 80.0 DZE ANTHOGYR PX34080 18-223395 00036633940025

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR