BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3" 1MM DEKOMPRESSOR KIT

    MDR report key: 1791559 · Received July 27, 2010

    Report

    Report Number
    2648666-2010-00331
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 25, 2010
    Report Date
    July 2, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    HRX
    PMA / PMN Number
    K032473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED THAT THE DEVICE WAS DISCARDED AT THE ACCOUNT. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

    Description of Event or Problem · 1

    DURING AN ANTERIOR CERVICAL FUSION PROCEDURE, THE TIP OF THE AUGER BROKE. IT WAS MANUALLY REMOVED FROM THE PATIENT. THIS ADDED APPROXIMATELY 10 MINUTES TO THE PROCEDURE. THE CASE WAS COMPLETED USING BACK UP EQUIPMENT. THERE WAS NO ADVERSE CONSEQUENCE REPORTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3" 1MM DEKOMPRESSOR KIT ARTHROSCOPE HRX STRYKER INSTRUMENTS PUERTO RICO 10034012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK