BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTORVISION FLUORO 3D

    MDR report key: 3122603 · Received May 15, 2013

    Report

    Report Number
    8043933-2013-00015
    Event Type
    Other
    Date Received
    May 15, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K070106
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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 THIS K-WIRE, POTENTIALLY CAUSED BY THE NAVIGATION SYSTEM, SINCE THE REFERENCE ARRAY WAS NOT ATTACHED ON THE BONE TO BE OPERATED ON. FOR THIS SPECIFIC CASE THE INVESTIGATION RESULTS COULD NEITHER CONFIRM NOR DISPROVE AN ACTUAL DISCREPANCY OF THE VIRTUAL DISPLAY INFO PROVIDED BY THE BRAINLAB NAVIGATION SYSTEM AND THE ACTUAL CURRENT VERTEBRA ANATOMY POSITION DURING THIS K-WIRE PLACEMENT. THE BRAINLAB NAVIGATION WORKED AS INTENDED: THE SURGEON MENTIONED DIFFICULT PT ANATOMY. THE OTHER 3 K-WIRES AND THE FINAL CORRECTION OF THE INITIALLY MISPLACED K-WIRE WERE PLACED AT THE INTENDED POSITIONS USING THE AID OF NAVIGATION AT THIS SURGERY. BRAINLAB INTENDS TO RE-ITERATE TO THIS USER 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 TO BE OPERATED ON WOULD NOT LEAD TO DISCREPANCIES BETWEEN VIRTUAL DISPLAY OF THE NAVIGATION AND ACTUAL CURRENT POSITION OF PT ANATOMY OF INTEREST.

    Description of Event or Problem · 1

    A SPINAL SURGERY FOR MINIMALLY INVASIVE STABILIZATION OF VERTEBRAS (L4-L5) HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE. ONE OUT OF 4 K-WIRES WAS PLACED AT AN UNINTENDED POSITION, FLUOROSCOPY VERIFICATION DURING THIS SURGERY REVEALED THAT THIS K-WIRE INTENDED TO BE PLACED AT THE RIGHT SIDE OF L4, WAS ACTUALLY POSITIONED IN THE DISC SPACE OF L4-L5. THE POSITION OF THIS K-WIRE WAS 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
    214820 VECTORVISION FLUORO 3D IMAGE GUIDED SURGERY SYSTEM / STEREOT. HAW BRAINLAB AG 22260 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other