BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1702175 · Received May 18, 2010

    Report

    Report Number
    1030489-2010-00653
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 20, 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. SUBMITTED PICTURES APPEAR TO SHOW SET SCREW THREAD CRESTS INCONSISTENTLY DAMAGED ON BOTH SIDES, CONSISTENT WITH POSSIBLE THREAD JUMPING AND RESULTING IN DAMAGED THREADS. 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 DURING A MIN-INVASIVE SPINAL PROCEDURE TO ADD POSTERIOR FIXATION INSTRUMENTATION AT L3-L4, THE L3 PLUG SLIPPED AND COULD NOT BE BROKEN OFF. THE L3 PEDICLE SCREW WAS REPLACED WITH A NEW ONE AND THE CASE WAS COMPLETED WITHOUT ANY ADD'L COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SET SCREW KWQ WARSAW ORTHOPEDIC INC. NA 0067487W

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR PEDICLE SCREW NOT IMPLANTED