BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINAL DRIVER

    MDR report key: 2546741 · Received April 20, 2012

    Report

    Report Number
    3008657535-2012-00034
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Date of Event
    April 3, 2012
    Report Date
    April 20, 2012
    Manufacturer
    THEKEN SPINE, LLC
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO ANOMALIES. INTEGRA RECEIVED THE DEVICE FOR EVAL. THE MARKS ON THE TIP INDICATE THAT THE DRIVER TIP WAS NOT FULLY SEATED IN THE LOCKING SCREW SOCKET. INTEGRA'S INVESTIGATION DETERMINED THAT THE PARTIAL INSERTION OVERSTRESSES THE END OF THE TIP, CAUSING FAILURE OF THE DEVICE. BREAKAGE OF THE TIP MAY ALSO BE RELATED TO OVERTIGHTENING. IF THE RATCHETING HANDLE AND NOT THE TORQUE LIMITING HANDLE IS USED THERE IS NO SAFETY MECHANISM TO PREVENT OVER TORQUING. THE ROOT CAUSE OF THIS FAILURE MAY BE A COMBINATION OF THE TWO METHODS OF USE. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FURTHER INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR OCCURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING A SPINAL SURGERY REVISION PROCEDURE, THE TIPS BROKE OFF THE DEVICE AS THE SURGEON WAS USING IT TO REMOVE THE IMPLANT. THE PROCEDURE WAS DONE BECAUSE OF PROGRESSION OF THE PT'S MEDICAL CONDITION. THERE WAS NO ALLEGED FAILURE OF THE IMPLANTED DEVICE. THE CONSTRUCTION WAS EXTENDED UP AND DOWN ONE LEVEL. THE SURGEON REMOVED THE CONSTRUCT IN ONE PIECE WHEN THE DEVICE BROKE. THERE WAS NO ADVERSE OUTCOME FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINAL DRIVER ATOLL MNI THEKEN SPINE, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1