BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1793141 · Received August 6, 2010

    Report

    Report Number
    1030489-2010-01024
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    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). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 8670855, 510K # K000453 WAS CLEARED IN THE UNITED STATES. DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. 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 PT UNDERWENT A TLIF USING MINI-INVASIVE PROCEDURE TO IMPLANT POSTERIOR FIXATION. DURING FINAL TIGHTENING, LEFT L4 SET SCREW COULD NOT BE BROKEN OFF. THE SET SCREW WAS REPLACED THREE TIMES BUT ALL FAILED. ULTIMATELY, L4 PEDICLE SCREW AND ROD WERE REPLACED TO NEW ONES; THE SET SCREW COULD FINALLY BE IMPLANTED AND BROKEN OFF. NO PT COMPLICATIONS OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SET SCREW KWQ WARSAW ORTHOPEDIC INC. NA 0067488W

    Patients

    Seq Age Sex Outcome Treatment
    1 ROD| PEDICLE SCREW