BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS REFERENCE CROSS PIN FRAME

    MDR report key: 3231824 · Received December 11, 2012

    Report

    Report Number
    1723170-2012-00704
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. RMA ISSUED. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT PART FINDS THE ATTACHMENT TUBE HAS MARKS OF ABRASION THAT WILL NOT ALLOW THE PERCUTANEOUS REFERENCE CROSS PIN FRAME TO SEAT PROPERLY. OTHERWISE, THE FRAME RETURNED GOOD GEOMETRY AND DIVOT ERROR READINGS. WEAR IS DEEMED TO HAVE CAUSED THE MALFUNCTION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE PERCUTANEOUS REFERENCE CROSS PIN FRAME BREECH IS NOT CLOSING PROPERLY. NO PT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS REFERENCE CROSS PIN FRAME NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 090904

    Patients

    Seq Age Sex Outcome Treatment
    1