BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3231831 · Received December 7, 2012

    Report

    Report Number
    1723170-2012-00687
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    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

    RMA ISSUED. MEDTRONIC EVALUATION OF RETURNED PART FINDS THE TIP OF THE INSTRUMENT IS NOT BROKEN OFF, BUT RATHER IT HAS BEEN TWISTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SOLERA REDUCTION DRIVER TIP BROKE OFF IN THE HEAD OF THE SCREW DURING A SPINAL FUSION PROCEDURE. THE SURGEON PUT THE ROD ON TOP OF IT AND CINCHED IT DOWN WITH A SET SCREW. THE SURGERY WAS COMPLETED WITH THE USE OF THE STEALTHSTATION S7 SYSTEM. NO NEGATIVE IMPACT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR