BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2446017 · Received February 10, 2012

    Report

    Report Number
    1030489-2012-00153
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    January 12, 2012
    Report Date
    January 12, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE PART # G8670855, LOT 0180164W, EXPIRATION DATE 10/05/2019; LOT 0180165W, EXPIRATION DATE 10/05/2019; LOT 0180166W, EXPIRATION DATE 10/05/2019. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 8670855, 510K # K000453 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT 0180164W IS 09/20/2011; THE MANUFACTURE DATE FOR LOT 0180165W IS 09/20/2011; THE MANUFACTURE DATE FOR LOT 0180166W IS 09/20/2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TLIF AT L5-S1 TO TREAT LUMBAR SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE SURGEON WAS NOT ABLE TO BREAK OFF THE SETSCREW DURING THE FINAL TIGHTENING. THE SURGEON REPLACED THE SETSCREW AND THE PEDICLE SCREW WITH NEW SCREWS. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR