BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1918512 · Received November 4, 2010

    Report

    Report Number
    1030489-2010-01363
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    MNI
    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 # 86746545, 510K# K000453 WAS CLEARED IN THE UNITED STATES. REVIEW OF THE SUBMITTED PICTURES APPEAR TO SHOW THE THREAD CRESTS AND FLANKS OF BOTH THE PEDICLE AND SET SCREW ARE DAMAGED; THIS DAMAGE APPEARS TO HAVE INITIATED AT THE START OF THE THREAD, CONSISTENT WITH MISALIGNMENT OF THE MAS HEAD AND SET SCREW 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 SPINAL PROCEDURE AT L1-L3 TO IMPLANT POSTERIOR FIXATION, THE SET SCREW COULD NOT BE BROKEN OFF AT LEFT L3. THE PEDICLE SCREW WAS ALSO REPLACED BECAUSE ITS THREAD WAS DAMAGED. THE CASE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SET SCREW MNI WARSAW ORTHOPEDIC INC. NA 0076161W

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR PEDICLE SCREW NOT IMPLANTED.