BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2445957 · Received February 10, 2012

    Report

    Report Number
    1030489-2012-00152
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 11, 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): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 86746545, 510K # K042025 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION AT L4-5 TO TREAT DEGENERATIVE SPONDYLOLISTHESIS AND STENOSIS. IT WAS REPORTED THAT AFTER THE FINAL TIGHTENING, A-P IMAGES REVEALED THAT LEFT ROD HAD NOT PASSED THROUGH BOTH LEFT SCREW HEADS. THE ROD AND LEFT SET SCREWS WERE REMOVED. DURING REMOVAL OF THE SETSCREW, THE SURGEON DEFORMED ONE OF THE SCREW HEADS; AS A RESULT, THE SCREW WAS REPLACED WITH A NEW LARGER SCREW. THE SURGEON REBUILT THE CONSTRUCT AND COMPLETED THE PROCEDURE 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 0173779W

    Patients

    Seq Age Sex Outcome Treatment
    1