BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNESYS LIS INSTRUMENTATION

    MDR report key: 607634 · Received May 26, 2005

    Report

    Report Number
    2184052-2005-00004
    Event Type
    Other
    Date Received
    May 26, 2005
    Date of Event
    April 21, 2005
    Report Date
    May 26, 2005
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    NQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGERY USING THE DYNESYS LIS INSTRUMENTS AND IMPLANTS, AND 1 BAK VISTA CAGE AT L5-S1, THE CASE REP REPORTED THE SURGEON HAVING GREAT DIFFICULTY GETTING THE ANTI-TORQUE T-HANDLE TO SIT ON THE SCREW IN THE PROPER TRAJECTORY SO THAT THE SET SCREW COULD BE INSERTED. EIGHT SET SCREWS WERE REPORTED STRIPPED DURING THE CASE AND RESULTED IN AN ADDITIONAL 2.5 HOURS OF SURGERY TIME. SEVERN (7) OF THE EIGHT (8) SET SCREWS WERE SUCCESSFULLY INSERTED INTO THE 8 PEDICLE SCREWS. NO SET SCREW WAS IMPLANTED INTO THE RIGHT L4 PEDICLE SCREW; HOWEVER, THE SET SCREWS AT L3, L5 AND S1 WERE SUCCESSFULLY INSERTED AND TORQUED DOWN INTO THE PEDICLE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNESYS LIS INSTRUMENTATION DYNESYS ANTI-TORQUE NQP ZIMMER SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other