BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1471397 · Received June 10, 2009

    Report

    Report Number
    1030489-2009-00528
    Event Type
    Malfunction
    Date Received
    June 10, 2009
    Date of Event
    May 11, 2009
    Report Date
    May 11, 2009
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPER
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). IMPLANT REMAINS IMPLANTED, PRODUCT EVALUATION IS NOT POSSIBLE AT THIS TIME. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. THE SUSPECT DEVICES IN USE ARE LOT # H08K9034 AND H08K9428. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. IN ADDITION, THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7540020, 510K # K052187 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE FOR OSSIFICATION OF LIGAMENTUM FLAVUM AT T2-T5 USING POSTERIOR FIXATION. IT WAS REPORTED THAT WHILE THE SURGEON WAS TRYING TO TIGHTEN THE SET SCREW AT RIGHT SIDE T2, THE SCREW DRIVER DID NOT FIRMLY CONNECT TO THE SET SCREW. THE BREAK OFF SET SCREW COULD NOT BE BROKEN OFF AT RIGHT SIDE T2. THE SURGEON CLOSED THE PATIENT WITH THE SET SCREW TAB INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SET SCREW KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPER MSD316 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR