BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® ZIREAL® POST 4.1(D) X 5(P) X 4(H) W/ZIREAL® HEXED SCREWS

    MDR report key: 3944882 · Received July 18, 2014

    Report

    Report Number
    0001038806-2014-00072
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    April 3, 2013
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PD051973
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME BIOMET 3I BECAME AWARE OF THIS EVENT, IT WAS NOT CONSIDERED REPORTABLE. SUBSEQUENT REVIEW OF REPORTING POLICIES HAS DETERMINED ABUTMENT FRACTURES FOR THIS PRODUCT TYPE SHOULD BE REPORTED AS MALFUNCTIONS. THIS EVENT WAS IDENTIFIED AS ONE REQUIRING RETROSPECTIVE REPORTING BASED ON A RECENT AUDIT OF COMPLAINT DATA AND ENHANCEMENTS MADE TO REPORTING POLICIES APPLICABLE TO ABUTMENT FRACTURES. INVESTIGATION RESULTS: UPON VISUAL INSPECTION, FOUND THAT A PORTION OF THE CERAMIC SIDE ON THIS ICAP454 HAS FRACTURED, THEREFORE, COMPONENT DOES NOT ENGAGE INTO MATING COMPONENTS PROPERLY.

    Description of Event or Problem · 1

    THE DOCTOR INDICATED THAT THE ZI-REAL ABUTMENT FRACTURED. THE DOCTOR WAS SHAPING THE ABUTMENT WITH A DIAMOND STONE WHEN HE SAW A CRACK IN THE STRUCTURE, HE WAS WORKING ON MASTER CAST AND THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421924 CERTAIN® ZIREAL® POST 4.1(D) X 5(P) X 4(H) W/ZIREAL® HEXED SCREWS CERTAIN® ZIREAL® POST 4.1(D) X 5(P) X 4(H) W/ZIREAL® HEXED SCREWS NHA BIOMET 3I N/A 1009853

    Patients

    Seq Age Sex Outcome Treatment
    1