BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE, PEDICLE, 2.25

    MDR report key: 2902339 · Received January 8, 2013

    Report

    Report Number
    1723170-2013-00005
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT NUMBER, OR SERIAL NUMBER, NOT AVAILABLE AT TIME OF THIS REPORT, BUT HAVE BEEN REQUESTED. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SN, THEREFORE, UNAVAILABLE AT THIS TIME. THE MEDTRONIC REPRESENTATIVE AT THE SITE REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH USE OF A SECOND INSTRUMENT. RMA ISSUED. SUSPECT DEVICE HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    EVALUATION OF SUSPECT PROBE FINDS: THE TIP OF THE PROBE IS VISIBLY BENT. WITH MARKERS ATTACHED THE PROBE RETURNS GOOD GEOMETRY ERROR BUT VERY HIGH DIVOT ERROR DUE TO THE BENT TIP. PHYSICAL DAMAGE AND DEFORMATION DIRECTLY CAUSED THE EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINE PROCEDURE, IT WAS FOUND THAT THE 2.25MM PEDICLE PROBE TIP TWISTED APPROXIMATELY 2 INCHES. THE SURGERY WAS COMPLETED WITH THE USE OF THE STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8992 PROBE, PEDICLE, 2.25 NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 120531

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR