BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1466036 · Received July 23, 2009

    Report

    Report Number
    1030489-2009-00689
    Event Type
    Malfunction
    Date Received
    July 23, 2009
    Report Date
    June 23, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. IN ADDITION, THIS DEVICE CATALOG NUMBER IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG NUMBER 7540020, 510K K052187 IS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SPINAL PROCEDURE FOR TREATMENT OF DLS WITH POSTERIOR FIXATION IMPLANTED AT L1-L5 ON THE RIGHT SIDE. SOMETIME POST-OP, A SETSCREW BACKED OUT AT RIGHT L5. NO PT COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR