BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1020995 · Received March 28, 2008

    Report

    Report Number
    1030489-2008-00163
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K000453
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECS. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SPINAL PROCEDURE, AT T9-L4 USING AUTOGRAFT WITH POSTERIOR FIXATION. THE SET SCREW AT T10 ON THE LEFT SIDE BACKED OUT AND THE SCREWS AT T9 AND T10 HAD LOOSENED APPROX FOUR MONTHS POST-OP. A REVISION SURGERY WAS PERFORMED APPROX FOUR MONTHS POST OP TO REPLACE THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SETSCREW KWP WARSAW ORTHOPEDIC INC. NA W07C3555

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention