BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1140046 · Received August 28, 2008

    Report

    Report Number
    1030489-2008-00464
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    October 13, 2006
    Report Date
    October 1, 2006
    Manufacturer
    WARSAW ORTHOPEDIC INC
    Product Code
    NQP
    PMA / PMN Number
    K050809
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVAL. A VISUAL EXAMINATION CONFIRMED THE ROD WAS FRACTURED AT THE SETSCREW APPROX 15.5MM FROM THE END OF THE ROD. BASED ON THE COLORATION OF MATERIAL IN THE CROSS SECTION AND THE CLEAN FRACTURE IT WAS DETERMINED THAT THE ROD MAY HAVE FRACTURED AS A RESULT OF A DIRECT LOCALIZED FORCE CONSISTENT WITH A TRAUMATIC EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A REVISION SURGERY TO REMOVE AND REPLACE A BROKEN SEMI RIGID ROD. THE PT REPORTEDLY SUFFERED SOME TYPE OF TRAUMA PRIOR TO THE ROD BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ROD NQP WARSAW ORTHOPEDIC INC NA W05K4485

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention