BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING HANDLE

    MDR report key: 1021605 · Received March 25, 2008

    Report

    Report Number
    2242816-2008-00038
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    March 2, 2008
    Report Date
    March 12, 2008
    Manufacturer
    EBI
    Product Code
    HXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TORQUE LIMITING HANDLE WAS NOT ABLE TO TURN THE SET SCREW DRIVER IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORQUE LIMITING HANDLE HXC EBI 500377

    Patients

    Seq Age Sex Outcome Treatment
    1