BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISSURE CARBIDE BUR, TAPERED

    MDR report key: 2437434 · Received January 19, 2012

    Report

    Report Number
    9616696-2012-00021
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    December 19, 2011
    Report Date
    December 26, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE BUR SUBJECT TO THE INVESTIGATION WAS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE AT THE NOTCH END. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION REQUIRED. IT WAS FURTHER REPORTED THAT A REPLACEMENT BUR WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FISSURE CARBIDE BUR, TAPERED EQJ STRYKER IRELAND LTD. 10350017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK