BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING T-HANDLE

    MDR report key: 3770729 · Received February 18, 2014

    Report

    Report Number
    2032593-2014-00009
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 27, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORT INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED 'DURING SURGERY, USING TORQUE LIMITING DRIVER TO TORQUE THE SET SCREWS; THE TORQUE DRIVER FAILED TO TORQUE THE SET SCREWS AT THE RECOMMENDED SPEC.' A SPARE DEVICE WAS AVAILABLE WHICH FUNCTIONED PROPERLY. SURGERY TIME WAS NOT DELAYED AND THERE WAS NO INJURY TO THE PT ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102004 TORQUE LIMITING T-HANDLE UCR NKB SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1