BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION TOOL

    MDR report key: 2045697 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00074
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Report Date
    July 15, 2010
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    HWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: UNKNOWN.

    Description of Event or Problem · 1

    BROKEN COMPRESSION TOOL. THE EVENT HAPPENED WHILE THE SURGEON WAS TRYING TO COMPRESS THE SCREW. THE SURGEON PUSHED THE REMAINDER OF THE SCREW DOWN WITH A SCREW DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION TOOL HWN INTERVENTIONAL SPINE, INC. 9039-01 050208-36

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention