BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSS-CUT FISSURE BUR, TAPERED

    MDR report key: 2062064 · Received March 16, 2011

    Report

    Report Number
    9616696-2011-00039
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO BURS SUBJECT TO THIS INVESTIGATION WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. MANUFACTURING RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS UNDETERMINED. THE LOT NUMBER ASSOCIATED WITH THE SECOND BUR IS 10286017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DENTAL PROCEDURE (WISDOM TOOTH REMOVAL), THE TIP OF TWO BURS BROKE. IT WAS ALSO REPORTED THAT THE SURGEON REMOVED THE BROKEN PIECES WITH TWEEZERS AND HAS NO CONCERNS ABOUT ANY PIECES BEING LEFT BEHIND IN THE PT. IT WAS FURTHER REPORTED THAT ANOTHER BUR WAS READILY AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSS-CUT FISSURE BUR, TAPERED DRILLS, BURS TREPHINES & ACCESSORIES HBE STRYKER IRELAND LTD. 10179017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK