BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1961752 · Received January 14, 2011

    Report

    Report Number
    1030489-2011-00043
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 17, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXTENDER HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE EXTENDER ASSEMBLY HAS BEEN RECEIVED IN POSITION EJECT. IN THIS POSITION THE NUT IS TURNING FREELY AND THE INNER SLEEVE IS NOT ENGAGED WITH NUT. THE INNER SLEEVE IS SLIGHTLY STICKING WANT TRYING TO MOVE IN OR OUT, HOWEVER A SIMPLE FLEXION OF THE TIP OF THE INNER SLEEVE ALLOWS A PROPER DISMANTLING AND ASSEMBLY WITH THE EXTERNAL SLEEVE AND CAN ENGAGE WITH THE NUT. THE ASSEMBLY HAS BEEN CONNECTED WITH A NEW BONE SCREW (B)(4) AND WAS FOUND TO CONNECT AND RETAIN PROPERLY THE BONE SCREW. THE INSTRUMENT WAS FOUND TO WORK PROPERLY: CAN BE ASSEMBLED, DISMANTLED AS WELL AS CONNECTED TO AN IMPLANT HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTENDER IS NO LONGER WORKING, THE INNER PART DOES NOT FUNCTION PROPERLY. ALTHOUGH THE INSTRUMENT WAS USED IN SURGERY, NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA RS10D020

    Patients

    Seq Age Sex Outcome Treatment
    1