BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYTEM

    MDR report key: 4001964 · Received August 12, 2014

    Report

    Report Number
    1030489-2014-03433
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    K052187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR TRANSFORAMINAL LUMBAR FUSION AT T4-L4 TO TREAT SCOLIOSIS. A YEAR POST-OP IT WAS FOUND ON FILMS THAT THE SET SCREW AT THE MOST DISTAL END OF THE CONSTRUCT ON THE LEFT SIDE MIGRATED FROM THE BONE SCREW. NO REVISION SURGERY IS SCHEDULED YET. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478734 CD HORIZON SPINAL SYTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR SET SCREW, ROD