BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1020022 · Received March 27, 2008

    Report

    Report Number
    1030489-2008-00150
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    December 18, 2007
    Report Date
    February 6, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWQ
    PMA / PMN Number
    K040962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THE ROD WAS FRACTURED 3CM FROM THE END OF THE ROD. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR L5-S1 SPONDYLOLISTHESIS WITH POSTERIOR FIXATION. IT WAS REPORTED THAT APPROXIMATELY 6 WEEKS POST-OP, THE SURGEON REVIEWED THE PATIENT AND FOUND THAT A ROD APPEARED BROKEN AT THE SACRAL JUNCTION. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 7 MONTHS POST-OP TO REMOVE THE BROKEN ROD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention