BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3102641 · Received May 9, 2013

    Report

    Report Number
    1723170-2013-00329
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE AND VERIFIED THAT THE SYSTEM WAS ACCURATE AND CALIBRATED CORRECTLY. SYSTEM PASSED ALL TESTING.

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN DID NOT PROVIDE ANY PATIENT DEMOGRAPHIC INFORMATION. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING AN AIS LUMBAR CURVE PROCEDURE, INSTRUMENTATION T11-L4, THERE WAS AN ALLEGED INACCURACY. THE CT-SCAN OF THE LOWER REGION AND SETTING SCREWS IN L4, L3, L2 AND L1 SHOWED NO ISSUES. THE SURGEON STARTED TO DO THE TH12 ON THE LEFT SIDE AND PREPARED THE PEDICLE AS USUAL. EVERYTHING WAS AS IT SHOULD AND IMAGING, NAVIGATION AND CLINICAL IMPRESSION INCLUDING ANATOMIC LANDMARKS AND TACTILE FEELING WAS GOOD AS WELL. THEN ANOTHER CT WAS PERFORMED FOR THE LAST SCREWS (T11+T12). LEFT SIDE T12: POINTER WAS PUT IN THE PEDICLE (THE PEDICLE WAS PREPARED WELL DURING THE FIRST SCAN AND HE WAS CONFIDENT IT WAS IN THE PEDICLE). THE IMAGING SHOWED THE TRAJECTORY WRONGLY LOCATED ALMOST IN THE CENTER OF THE SPINAL CANAL. THE SURGEON CHOSE TO DISCONTINUE THE USE OF NAVIGATION. NO NEGATIVE IMPACT TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204536 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1