BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEZ SPINE LAGUNA PEDICLE SCREW SYSTEM

    MDR report key: 1060148 · Received June 11, 2008

    Report

    Report Number
    3005032381-2008-00010
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 12, 2008
    Manufacturer
    ALLEZ SPINE, LLC
    Product Code
    MNI
    PMA / PMN Number
    K050060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY'S INVESTIGATION CONCLUDED THAT THE HEX DRIVER BROKE AS A RESULT OF THE APPLICATION OF TORQUE EXCEEDING THE DESIGN LIMIT OF THE DRIVER. THE TORQUE LIMITING DRIVER HANDLE RECOMMENDED TO PERFORM FINAL TIGHTENING LIMITS THE TORQUE FORCE APPLIED TO THE LOCKING NUT TO 10.16NM +/- 10%. IN THIS CASE, A NON-TORQUE LIMITING HANDLE WAS USED. THE APPLICATION OF A FORCE LARGER THAN APPROXIMATELY 16 - 17NM CAN RESULT IN THE DEFORMATION/BREAKAGE OF THE TIP OF THE HEX DRIVER.

    Description of Event or Problem · 1

    DURING INSTALLATION OF THE LAGUNA PEDICLE SCREW SYSTEM, THE SURGEON USED A NON-TORQUE LIMITING HEX DRIVER HANDLE TO PERFORM FINAL TIGHTENING OF THE LOCKING NUTS. THE TIP OF THE HEX DRIVER SHEARED OFF AND WAS LEFT EMBEDDED IN THE LOCKING NUT IN THE PATIENT. NO OTHER COMPLICATIONS OR ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEZ SPINE LAGUNA PEDICLE SCREW SYSTEM SPINAL FIXATION SYSTEM MNI ALLEZ SPINE, LLC TRG805

    Patients

    Seq Age Sex Outcome Treatment
    1 Other