BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND OSTEON BUR, ELITE, SOFT TOUCH

    MDR report key: 2002291 · Received January 27, 2011

    Report

    Report Number
    9616696-2011-00013
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 3, 2011
    Manufacturer
    STRYKER INSTRUMENTS CORK
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT AT THE TIME OF MANUFACTURE. THE BUR SUBJECT TO THIS EVENT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUR WAS DULL. IT WAS ALSO REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES OR DELAY AS A RESULT OF THIS EVENT. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROUND OSTEON BUR, ELITE, SOFT TOUCH DRILLS, BURS, TREPHINES & ACCESSORIES HBF STRYKER INSTRUMENTS CORK 10272017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK