BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER SPINE

    MDR report key: 593059 · Received April 6, 2005

    Report

    Report Number
    MW1035209
    Event Type
    Malfunction
    Date Received
    April 6, 2005
    Date of Event
    April 4, 2005
    Report Date
    April 6, 2005
    Manufacturer
    STRYKER
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGICAL INSTRUMENTS WERE BROUGHT INTO HOSP'S STERILE PROCESSING DEPT FROM THE MANUFACTURER, AND THE INSTRUMENTS WERE SOILED WITH DRIED ON BLOOD. THESE INSTRUMENTS ARE SUPPOSED TO BE CLEANED AND DECONTAMINATED BEFORE DELIVERY TO ANOTHER HOSPITAL. STAFF DID CLEAN AND REMOVE THE DRIED BLOOD PRIOR TO STERILIZATION SO THE INSTRUMENTS COULD BE USED ON THE SURGICAL PROCEDURE FOR WHICH THEY HAD BEEN ORDERED. THE FOLLOWING IS A LIST OF THE INSTRUMENTS THAT WERE SOILED: ROD CUTTER, PERSUADER, PLATE HOLDER, HOOK FORCEP, ANTI-TORGUE POLYAXIAL SCREWDRIVER, PROBE DEPTH GAUGE, DRILL GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER SPINE OASYS SYSTEM -2 TRAYS- LXH STRYKER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *