BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1702227 · Received May 18, 2010

    Report

    Report Number
    1030489-2010-00649
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Date of Event
    April 20, 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. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE 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 SPECS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A PLIF BY MINI-INVASIVE PROCEDURE TO FUSE L4-5 TO IMPLANT INTERBODY DEVICES AND POSTERIOR FIXATION. THE PLUG COULD NOT BE BROKEN OFF AFTER COMPRESSION. THE THREAD OF THE PLUG AND INSIDE OF THE SCREW HEAD WERE BOTH DAMAGED. THE PEDICLE SCREW WAS REPLACED WITH A NEW ONE, AND THE PROCEDURE 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 35 YR PEDICLE SCREW, NOT IMPLANTED