BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1152836 · Received September 4, 2008

    Report

    Report Number
    1030489-2008-00493
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 5, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT SURGERY FOR IMPLANT OF POSTERIOR SPINAL FIXATION AT L4-S1 WITH RODS AND SCREWS. APPROXIMATELY 3 MONTHS POST-OP IT WAS REPORTED THAT THE PT WAS HAVING RADICULAR PAIN FROM THE RIGHT L5 SCREW. IT WAS REPORTED THAT THE RIGHT L5 SCREW WAS PLACED TOO FAR MEDIAL AND THAT THE POOR SCREW PLACEMENT WAS CAUSING THE PATIENT'S PAIN. THE PT UNDERWENT A REVISION SURGERY TO REMOVE THE RIGHT L5 SCREW AND REPLACE THE RIGHT ROD. THE PATIENT'S SYMPTOMS HAVE REPORTEDLY IMPROVED.

    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 50'S Required Intervention