BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2185661 · Received August 1, 2011

    Report

    Report Number
    1030489-2011-00998
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Date of Event
    July 5, 2011
    Report Date
    September 14, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF RETURNED CROSSLINK NOTED ONE SET SCREW IS MISSING AND NOT RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPIC EXAMINATION DID NOT IDENTIFY AND CRACK OR BREAKAGE OF THE RETURNED SET SCREW, WITH WEAR NOTED ON THE TOP AND BOTTOM THREAD OF THE SET SCREW. FUNCTIONALLY EVALUATED THE ASSEMBLY BY FULLY ENGAGING THE RETURNED SET SCREW ON BOTH SIDES. NO ISSUES NOTED WITH ENGAGEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8549011, 510K # K020709 WAS CLEARED IN THE UNITED STATES. DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NUT OF THE LOW PROFILE CROSSLINK BROKE DURING THE SET SCREW WAS BEING SCREWED DOWN. ALL FRAGMENTS WERE RETRIEVED. THE CROSSLINK WAS REPLACED WITH A BIGGER ONE. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA W07L5599

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR