BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSS-CUT FISSURE BUR, TAPERED

    MDR report key: 1991080 · Received February 11, 2011

    Report

    Report Number
    9616696-2011-00018
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY 3 BURS SUBJECT TO THIS MDR WERE RETURNED TO THE MFR FOR EVAL. IT WAS VISUALLY CONFIRMED THAT THE HEADS OF THE BUR WERE BROKEN FROM THE SHANKS. MFG RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DENTAL PROCEDURE (SECTIONING A MOLAR TOOTH), 10 BURS BROKE AT THE HEAD. IT WAS ALSO REPORTED THAT THE BROKEN PIECES FELL INTO THE SURGICAL SITE, AND THAT ALL BROKEN PIECES WERE REMOVED. IT WAS FURTHER REPORTED THAT AN X-RAY WAS PERFORMED TO CONFIRM NO BROKEN PIECES WERE LEFT BEHIND. IT WAS ALSO REPORTED THAT THIS EVENT DELAYED THE PROCEDURE BY 45 MINUTES.

    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. 10286017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention