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: 3983057 · Received August 6, 2014

    Report

    Report Number
    0001038806-2014-00100
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    January 5, 2014
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PD051973
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE 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: VISUAL INSPECTION OF THE RETURNED DEVICE DETERMINED THAT A SEPARATION (DELAMINATION) OF THE CERAMIC POST FROM THE TITANIUM INTERFACE HAD NOT OCCURRED, BUT RATHER A FRACTURE OF THE CERAMIC POST. A LIKELY CAUSE IS EXCESSIVE FORCE / OVER PREPARATION MAKING THE WALLS THIN. ALL 50 ABUTMENTS FROM THIS LOT HAVE BEEN SHIPPED AND THIS IS THE ONLY REPORTED INCIDENT TO DATE. THE REVIEW OF THE DHR RECORDS DID NOT PROVIDE ANY INDICATION OF A MANUFACTURING DEVIATION THAT WOULD CAUSE THIS CONDITION.

    Description of Event or Problem · 1

    THE DOCTOR INDICATED THE DEVICE FRACTURED. THE DOCTOR PLACED 2 ZIREAL POSTS ON TEETH #29+30 ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT RETURNED WITH A LOOSE BRIDGE. THE ZIREAL ABUTMENT ON #29 HAD FRACTURED. THERE WAS NO PATIENT INJURY OR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461583 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 1109336

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR