BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON LEGACY SPINAL SYSTEM

    MDR report key: 1041217 · Received May 8, 2008

    Report

    Report Number
    1030489-2008-00225
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 10, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT RETURNED TO MEDTRONIC FOR EVAL. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR PROCEDURE, THE SURGEON COULD NOT BREAK-OFF ONE OF THE SETSCREWS. A SECOND SETSCREW WAS TRIED WITH THE SAME RESULT. THE SURGEON DECIDED TO NOT IMPLANT A SETSCREW AT THAT LEVEL AND DID NOT WANT TO REPLACE THE BONE SCREW WHICH WOULD REQUIRE A FULL DISMANTLING OF THE ROD. THE SURGEON REPORTEDLY DID NOT USE THE COUNTERTORQUE WHICH WAS SAID TO BE "TOO SHORT TO GET INTO THE WOUND". NO PT COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK