BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION TOOL

    MDR report key: 2045636 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00051
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 29, 2008
    Report Date
    March 12, 2008
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    HWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: ONE POSSIBLE REASON FOR THE MALFUNCTION WAS THAT THE COMPRESSION TOOL WAS UNSCREWED DURING USE OR USER USED EXCESS FORCE. EXPLANATION: THE PRODUCT WAS VISUALLY ANALYZED AND IT WAS DETERMINED THAT THE PRODUCT DID NOT DISPLAY ANY SIGN OF DEFECT. INITIALLY, IT WAS DETERMINED THE EVENT WAS NOT REPORTABLE. ON A SUBSEQUENT RE-REVIEW, IT WAS DETERMINED THIS EVENT SHOULD HAVE BEEN REPORTED. DEVICE EVALUATION: RETURNED COMPRESSION TOOL WAS VISUALLY INSPECTED. COMPRESSION TOOL WORKED PROPERLY. NO OTHER OBSERVATIONS.

    Description of Event or Problem · 1

    COMPRESSION TOOL. DEVICE (9024-00) ON LEFT SIDE, BECAME STUCK ON THE COMPRESSION TOOL (9049-00).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION TOOL HWN INTERVENTIONAL SPINE, INC. 9049-00 / 9024-00 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention