BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER, OPEN SPINE CLAMP

    MDR report key: 2193624 · Received July 13, 2011

    Report

    Report Number
    1723170-2011-01224
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 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 PT INFO AS THERE WAS NO PT. LOT NUMBER IS NOT AVAILABLE AT TIME OF THIS REPORT. DEVICE MANUFACTURE DATE UNAVAILABLE AT TIME OF THIS REPORT AS IT IS DEPENDENT ON THE LOT NUMBER. MEDTRONIC REP STATED THAT PART REPLACEMENT RESOLVED THE ISSUE. NO RETURN OF BROKEN PART EXPECTED.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED AN OPEN CLAMP DRIVER WAS BROKEN. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PATIENT WAS PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1