BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTORVISION FLUORO 3D

    MDR report key: 3177066 · Received June 12, 2013

    Report

    Report Number
    8043933-2013-00018
    Event Type
    Other
    Date Received
    June 12, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K070106
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RISK TO THE PT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, ALTHOUGH THERE IS NO INDICATION OF A (SYSTEMATIC) ERROR OR MALFUNCTION OF THE BRAINLAB DEVICE; THE CORRESPONDING BRAINLAB MEASURES TO REDUCE THIS ALREADY ANTICIPATED RISK TO BE AS LOW AS REASONABLY PRACTICABLE ARE IN PLACE; ACCORDING TO THE HOSPITAL, THERE IS NO NEGATIVE EFFECT TO THE PT, AND THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL. THE VIRTUAL DISPLAY OF THE BRAINLAB NAVIGATION MIGHT NOT HAVE BEEN AS ACCURATE TO THE PT ANATOMY AS DESIRED DURING THE PLACEMENT OF THESE K-WIRES, POTENTIALLY CAUSED BY: A SHIFT OF THE REFERENCE ARRAY DUE TO A LESS THAN IDEAL FIXATION DURING THIS SURGERY; MOVEMENT OF THE VERTEBRA THAT COULD NOT BE COMPENSATED BY THE NAVIGATION SYSTEM, SINCE THE REFERENCE ARRAY WAS NOT ALWAYS ATTACHED ON THE BONE OPERATED ON. BRAINLAB INVESTIGATION COULD NEITHER CONFIRM NOR DISPROVE AN ACTUAL DISCREPANCY OF THE INFORMATION VIRTUALLY DISPLAYED BY THE BRAINLAB NAVIGATION AND THE ACTUAL CURRENT ANATOMY AND INSTRUMENT POSITIONS. BRAINLAB INTENDS TO RE-ITERATE TO THIS CUSTOMER THE NECESSITY OF RIGID FIXATION OF THE REFERENCE ARRAY; THAT ONLY IF THE REFERENCE ARRAY IS ATTACHED ON THE BONE TO BE OPERATED ON (AS REQUIRED IN THE BRAINLAB INSTRUCTIONS FOR USE), POTENTIAL MOVEMENTS OF THE BONE OPERATED ON WOULD NOT LEAD TO DISCREPANCIES BETWEEN VIRTUAL NAVIGATION DISPLAY AND ACTUAL CURRENT POSITION OF PT ANATOMY OF INTEREST; THE REQUIREMENT 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-T10 HAS BEEN PERFORMED, WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE FOR PLACEMENT OF K-WIRES. PEDICLE SCREWS WERE INSERTED WITHOUT USING NAVIGATION FOLLOWING THESE K-WIRES. FIVE OUT OF TEN K-WIRES WERE PLACED AT AN UNINTENDED POSITION. INTRA-OPERATIVE CT VERIFICATION DURING THIS SURGERY REVEALED UNINTENDED POSITIONS OF 5 PEDICLE SCREWS FOLLOWING THERE K-WIRE POSITIONS. THESE PEDICLE SCREWS WERE SHIFTED BY APPROX 5MM TO THE LEFT SIDE. THE POSITIONS OF THESE PEDICLE SCREWS WERE CORRECTED DURING THE SAME SURGERY. ACCORDING TO THE HOSPITAL, THERE IS NO NEGATIVE EFFECT TO THE PT, AND THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267413 VECTORVISION FLUORO 3D IMAGE GUIDED SURGERY SYSTEM/STEREOT. HAW BRAINLAB AG 22260 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other