BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2882308 · Received December 20, 2012

    Report

    Report Number
    1723170-2012-00741
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 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

    BASED ON THE EVENT DESCRIPTION, IT WAS NOTED THAT PATIENT ANATOMY TO FRAME WAS BUMPED BY A PA WHICH LED TO THE INACCURACY. THEREFORE, OPERATOR TECHNIQUE CAUSED THE REPORTED EVENT AND THE SOFTWARE BEHAVED AS DESIGNED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THEY WERE 1 CM INACCURATE IN THE ANTERIOR/POSTERIOR DIRECTION DURING NAVIGATION. THIS WAS DURING A SPINAL FUSION CASE USING THE O-ARM AND S7. INACCURACY WAS NOTICED PARTWAY THROUGH NAVIGATION. THEY WERE NAVIGATING THE BALL TIPPED PASSIVE PLANAR. THE SURGEON'S PA SAID HE BUMPED THE REFERENCE FRAME ON THE PERC PIN. THEY ALSO DID DECOMPRESSION BEFORE PLACING THE SCREWS. THEY DID NOT RESPIN THE PATIENT. THEY PROCEEDED WITH THE CASE NOTING THE INACCURACY. NO NEGATIVE IMPACT TO THE PATIENT WAS 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