BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHRO-CARE SPINE PARALLAX EZ FLOW

    MDR report key: 1595332 · Received February 2, 2010

    Report

    Report Number
    1595332
    Event Type
    Malfunction
    Date Received
    February 2, 2010
    Date of Event
    January 30, 2009
    Report Date
    February 5, 2009
    Manufacturer
    ARTHRO-CARE
    Product Code
    KIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A VERTEBROPLASTY PROCEDURE, THE SHAFT OF THE CANNULA SNAPPED LEAVING THE DISTAL PORTION OF THE CANNULA WITHIN THE PEDICLE AT L3. ATTEMPT TO REMOVE THE CANNULA WAS UNSUCCESSFUL. DECISION MADE TO LEAVE THE PORTION OF THE CANNULA IN THE PEDICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHRO-CARE SPINE PARALLAX EZ FLOW DIAMOND NEEDLE WITH THREADED CANNULA KIH ARTHRO-CARE M200447

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other