BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL SPEED CEMENT INJECTION GUN

    MDR report key: 2230985 · Received July 19, 2011

    Report

    Report Number
    1811755-2011-02614
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    JDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN INVESTIGATION IS ANTICIPATED. THIS REPORT WILL BE UPDATED IF THE INVESTIGATION REQUIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS METAL DEBRIS COMING FROM THE DEVICE FOLLOWING STERILIZATION. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL SPEED CEMENT INJECTION GUN JDZ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK