BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1210751 · Received October 23, 2008

    Report

    Report Number
    1030489-2008-00587
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 25, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANTED DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION, THE IMAGES OF EXPLANTED SCREWS WERE REVIEWED. THE PICTURES SHOW THAT TWO SCREWS ARE BROKEN AT MIDDLE OF THE TREADED POST. 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 PATIENT UNDERWENT A SPINAL PROCEDURE AT L1/3 FOR L2 TRAUMA USING POSTERIOR FIXATION. IT WAS NOTICED AT UNKNOWN TIME POST OP THAT TWO BONE SCREWS WERE BROKEN. THE PATIENT WAS REPORTEDLY ASYMPTOMATIC AND FUSION WAS NOT COMPLETED. A SECONDARY SURGERY WAS PERFORMED APPROXIMATELY NINE MONTHS POST OP AND THE BROKEN SCREWS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM BONE SCREW KWP WARSAW ORTHOPEDIC INC. NA W07D0669

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention