BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAIN ZIREAL ABUTMENT

    MDR report key: 1884250 · Received October 27, 2010

    Report

    Report Number
    1038806-2010-00003
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    March 11, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K991947
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENGINEERING INVESTIGATION WAS PERFORMED BASED UPON THE PRODUCT RETURNED AND WITH CONSIDERATION OF THE EVENTS AS DESCRIBED BY THE CLINICIAN FROM THE ADVERSE EVENT FORM. NO CONCLUSION WAS REACHED GIVEN THE LIMITED INFORMATION PROVIDED BY THE COMPLAINANT AS WELL AS THE ABSENCE OF CONCLUSIVE EVIDENCE TO DEFINITIVELY ESTABLISH FAILURE CAUSE. CLINICALLY, INFECTION WOULD LIKELY BE LOCALIZED TO THE IMPLANT SITE AND WOULD BE UNLIKELY TO CAUSE OR RESULT IN A SYSTEMIC INFECTION.

    Description of Event or Problem · 1

    DR. INDICATED ZIREAL ABUTMENT SEPARATED FROM THE TITANIUM CONNECTION. TORQUE WRENCH WAS USED TO SEAT THE ABUTMENT. THERE WAS DISINFECTION OR STERILIZATION TREATMENTS PERFORMED ON THE PIECE. NEITHER THE DOCTOR NOR THE LAB MADE ANY ADJUSTMENTS TO THE PIECE IN ANY WAY. PORCELAIN WAS CEMENTED TO THE ABUTMENT. ABUTMENT WAS FULLY SEATED. RADIOGRAPH PROVIDED SHOWING FINAL SEATING. THE PATIENT DID HAVE AN INFECTION AFTER ABUTMENT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERTAIN ZIREAL ABUTMENT CERTAIN ZIREAL ABUTMENT NHA BIOMET 3I ICAP454 719672

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention