BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTORVISION FLUORO 3D

    MDR report key: 3255877 · Received July 22, 2013

    Report

    Report Number
    8043933-2013-00022
    Event Type
    Other
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K070106
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RISK TOT HE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, ALTHOUGH THERE IS NO INDICATION OF A MALFUNCTION OR DEFECT OR (SYSTEMATIC) ERROR OF THE BRAINLAB DEVICE, THE CORRESPONDING BRAINLAB MEASURES TO MINIMIZE THIS ALREADY ANTICIPATED RISK AS LOW AS REASONABLY PRACTICABLE ARE IN PLACE. THE VIRTUAL DISPLAY OF THE BRAINLAB NAVIGATION APPEARS TO NOT HAVE BEEN AS ACCURATE TO THE PATIENT ANATOMY AS DESIRED DURING THE PLACEMENT OF THESE K-WIRES / PEDICLE SCREWS. THIS WAS MOST LIKELY CAUSED BY A MOVEMENT OF THE REFERENCE ARRAY DURING THIS SURGERY, WHICH THE USER RECOGNIZED AFTER THE PLACEMENT OF THE THESE PEDICLE SCREWS. THE MOVEMENT OF THE REFERENCE ARRAY MOST LIKELY OCCURRED DUE TO A NOT SUFFICIENTLY RIGID/TIGHT FIXATION AT THIS SURGERY. APPARENTLY THIS SITUATION WAS NOT DETECTED BY THE USER WITH THE ACCURACY VERIFICATION FUNCTIONS WITHIN THE BRAINLAB NAVIGATION, EVEN THOUGH THE NAVIGATION SOFTWARE DISPLAYED MESSAGES OF "REFERENCE MOVEMENT DETECTION" DURING THIS SURGERY. BRAINLAB INTENDS TO RE-ITERATE TO THIS CUSTOMER THE NECESSITY OF RIGID FIXATION OF THE REFERENCE ARRAY, THE REQUIREMENTS FOR ADEQUATE ACCURACY VERIFICATION WITH THE FUNCTIONS AVAILABLE IN THE NAVIGATION SOFTWARE.

    Description of Event or Problem · 1

    A SPINAL SURGERY FOR MINIMALLY INVASIVE POSTERIOR PEDICLE (VERTEBRA) FUSION OF L3 TO L4 HAS BEEN PERFORMED, WITH THE AID OF THE VIRTUAL DISPLAY BY THE BRAINLAB NAVIGATION FOR THE PLACEMENT OF THE K-WIRES AND PEDICLE SCREWS. TWO OUT OF FOUR PEDICLE SCREWS WERE PLACED AT AN UNINTENDED POSITION. INTRA-OPERATIVE FLUORO VERIFICATION DURING THIS SURGERY REVEALED THAT THE 2 PEDICLE SCREWS ON THE RIGHT SIDE (L3 AND L4) WERE PLACED MORE SUPERIOR THAN INTENDED. EXACT VALUES OF THE DEVIATIONS (MM) OF THESE PEDICLE SCREWS COULD NOT BE RETRIEVED NOR RE-CONSTRUCTED BY BRAINLAB. THE POSITIONS OF THESE PEDICLE SCREWS WERE CORRECTED DURING THE SAME SURGERY. ACCORDING TO THE HOSPITAL, THERE IS NO NEGATIVE EFFECT TO THE PATIENT, AND THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340987 VECTORVISION FLUORO 3D IMAGE GUIDED SURGERY SYSTEM / STEROT. HAW BRAINLAB AG 22260 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other