BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CDO SYSTEM

    MDR report key: 589889 · Received April 6, 2005

    Report

    Report Number
    2029012-2005-00010
    Event Type
    Malfunction
    Date Received
    April 6, 2005
    Date of Event
    January 24, 2005
    Report Date
    March 29, 2005
    Manufacturer
    INTERPORE CROSS INTL.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE ALIGNING CANNULA WOULD NOT PASS THROUGH THE OUTER CANNULA. THE SURGEON USED A BACK-UP SET TO COMPLETE THE CASE. THE PATIENT IS FINE, 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 407807/38510

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO