BEUDAMED
    FDA Adverse Event Summary report: N

    VECTORVISION NAVIGATION SW SPINE (VERS. 5.6.0)

    MDR report key: 4131252 · Received September 12, 2014

    Report

    Report Number
    8043933-2014-00032
    Date Received
    September 12, 2014
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K053159
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED, SINCE SCREWS WERE NOT PLACED AS INTENDED WITH THE BRAINLAB DEVICE INVOLVED, ALTHOUGH: THERE IS NO INDICATION OF A MALFUNCTION 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, ACCORDING TO THE HOSPITAL, THERE WAS NO NEGATIVE EFFECT TO THE PT DUE TO THIS ISSUE. ACCORDING TO THE RESULTS OF BRAINLAB INVESTIGATION AND THE INFO PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE MAIN ROOT CAUSE FOR THE SCREW MISPLACEMENT IS THE USAGE OF RE-STERILIZED DISPOSABLE REFLECTIVE MARKER SPHERES. THIS CAN RESULT IN DAMAGE OR DEFORMATION OF THE SPHERES RESULTING IN CORRESPONDING DEVIATION OF THE INSTRUMENT POSITIONS VIRTUALLY DISPLAYED IN THE NAVIGATION COMPARED TO THE ACTUAL PT ANATOMY. THERE IS NO INDICATION OF A MALFUNCTION OR SYSTEMATIC ERROR OF THE BRAINLAB DEVICE. CORRESPONDING BRAINLAB MEASURES TO REDUCE THE RISK TO BE AS LOW AS REASONABLE PRACTICABLE ARE IN PLACE. BRAINLAB INTENDS TO OFFER AN ADDITIONAL TRAINING TO THIS HOSPITAL.

    Description of Event or Problem · 1

    A SPINE SURGERY (MINIMAL INVASIVE STABILIZATION OF L2-L3) WAS PERFORMED WITH THE AID OF BRAINLAB VV SPINE 5.6 NAVIGATION SYSTEMS. DURING THE PROCEDURE THE SURGEON: ATTACHED THE NAVIGATION REFERENCE CLAMP ON VERTEBRA LL. PERFORMED THE REGISTRATION OF THE PATIENT (MATCHING OF VIRTUAL DISPLAY OF PATIENT IMAGE DATA AND ACTUAL PATIENT ANATOMY) WITH CT-FLUORO MATCHING PROCEDURE. VERIFIED THE ACCURACY OF THE REGISTRATION ON THE REFERENCE CLAMP. PLACED THE SCREWS IN L2 AND L3 WITH THE AID OF THE NAVIGATED POINTER AND STRAIGHT PROBE (BRAINLAB INSTRUMENTS) AND A SCREWDRIVER THAT WAS NOT NAVIGATED. VERIFIED THE LOCATION OF THE SCREWS BY X-RAY (USING THE C-ARM) AND REALIZED THEY WERE NOT PLACED IN THE INTENDED POSITION. ABORTED NAVIGATION AND REPOSITIONED THE SCREWS USING THE C-ARM. THE SURGEON COMPLETED THE CASE SUCCESSFULLY. ACCORDING TO THE HOSPITAL THERE HAVE BEEN NO NEGATIVE CLINICAL EFFECTS FOR THIS SPECIFIC PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565844 VECTORVISION NAVIGATION SW SPINE (VERS. 5.6.0) IMAGE GUIDED SURGERY SYSTEM/STEREOT. HAW BRAINLAB AG 22060D NA

    Patients

    Seq Age Sex Outcome Treatment
    1