BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CDO SYSTEM

    MDR report key: 589885 · Received April 6, 2005

    Report

    Report Number
    2029012-2005-00009
    Event Type
    Malfunction
    Date Received
    April 6, 2005
    Date of Event
    December 30, 2004
    Report Date
    March 10, 2005
    Manufacturer
    INTERPORE CROSS INTL.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE DISTAL TIP SEPARATED FROM THE CANNULAE AS THE MODULAR TAMP WAS BEING UNSCREWED. FURTHERMORE, IT WAS LATER LEARNED THAT THE SURGEON MAY HAVE POUNDED THE CANNULAE INTO DENSE BONE WHICH COULD HAVE LOOSENED THE TIP OF THE CANNULAE. THE PATIENT IS FINE, AND THE CASE COMPLETED UNEVENTFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CDO SYSTEM ORTHOPEDIC MANUAL INSTRUMENT LXH INTERPORE CROSS INTL. NA 407807/304112

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO