BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1070060 · Received July 3, 2008

    Report

    Report Number
    1030489-2008-00306
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    May 14, 2008
    Report Date
    June 4, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO REVISION SURGERY HAS TAKEN PLACE; THEREFORE, NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. AN X-RAY SHOWING AN AXIAL VIEW OF THE CONSTRUCT CONFIRMS THE FRACTURE OF THE MID-THREAD AREA OF THE PEDICLE SCREW. POSITION OF SCREW APPEARS NORMAL. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT X-RAYS TAKEN APPROX 6 1/2 MONTHS POST-OP REVEALED A BROKEN PEDICLE SCREW ON THE LEFT SIDE OF THE POSTERIOR CONSTRUCT. THE PT IS EXPERIENCING SOME PAIN AND THE SURGEON IS CONTINUING TO MONITOR THE PATIENT. FUSION IS REPORTED TO BE IN PROGRESS, BUT IT IS UNKNOWN IF COMPLETE. NO REVISION SURGERY HAS BEEN PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SCREW KWP WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK