BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 2062534 · Received March 21, 2011

    Report

    Report Number
    1723170-2011-00693
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION AS NO PATIENT WAS INVOLVED IN THIS CONCERN. DEVICE MANUFACTURE DATE NOT AVAILABLE AT TIME OF THIS REPORT. PART DISPOSED OF. VISUAL EXAMINATION AT TIME OF INCIDENT INDICATED THAT THE THREADS OF THE CLAMP WERE STRIPPED; IF THIS OCCURRED DURING SURGICAL USE, THE FRAME WOULD BE MORE LIKELY TO MOVE AND COULD CAUSE INACCURACY.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED AN OPEN SPINE CLAMP THAT WAS STRIPPED. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPEN SPINE CLAMP, TITANIUM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 177008

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE