BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSS-CUT FISSURE BUR, LONG TAPERED

    MDR report key: 2102946 · Received May 12, 2011

    Report

    Report Number
    9616696-2011-00074
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 15, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BUR SUBJECT TO THIS INVESTIGATION WAS NOT RETURNED TO THE MFR FOR EVAL. 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 SURGICAL PROCEDURE, THE BUR BROKE IN THE PT'S MOUTH. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION. IT WAS FURTHER REPORTED THAT THE SURGERY WAS DELAYED BY TWO MINUTES TO OBTAIN A REPLACEMENT BUR AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSS-CUT FISSURE BUR, LONG TAPERED EQJ STRYKER IRELAND LTD. 10260017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK