BEUDAMED
    FDA Adverse Event Summary report: N

    SPINE & TRAUMA ICT; SW VERSION 1.0.2

    MDR report key: 3896167 · Received June 12, 2014

    Report

    Report Number
    8043933-2014-00020
    Date Received
    June 12, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BRAINLAB AG
    Product Code
    OLO
    PMA / PMN Number
    K083310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A RISK TO THE 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 BRAINLAB DEVICE WORKS AS INTENDED. THE CORRESPONDING BRAINLAB MEASURES TO MINIMIZE THIS ALREADY ANTICIPATED RISK AS LOW AS REASONABLY PRACTICABLE ARE IN PLACE. ACCORDING TO THE HOSPITAL (SURGEON), THERE IS NO NEGATIVE EFFECT TO THE PATIENT, AND THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL. THE VIRTUAL DISPLAY OF THE BRAINLAB NAVIGATION MIGHT NOT HAVE BEEN AS ACCURATE TO THE PATIENT ANATOMY AS DESIRED DURING THE PLACEMENT OF THESE K-WIRES FOR THE RESULTING PEDICLE SCREWS, CAUSED BY POTENTIAL MOVEMENTS OF THE REFERENCE ARRAY DUE TO NOT SUFFICIENTLY RIGID FIXATION TO THE SPINOUS PROCESS (USER FIXATED IN BETWEEN TWO SPINOUS PROCESSES). OF THE VERTEBRA THAT COULD NOT BE COMPENSATED BY THE NAVIGATION SYSTEM, SINCE THE REFERENCE ARRAY WAS NOT ATTACHED ON THE BONE OPERATED ON. BRAINLAB INVESTIGATION COULD NEITHER CONFIRM NOR DISPROVE AN ACTUAL DISCREPANCY OF THE INFO VIRTUALLY DISPLAYED BY THE BRAINLAB NAVIGATION AND THE ACTUAL CURRENT ANATOMY AND INSTRUMENT POSITIONS. BRAINLAB INTENDS TO RE-ITERATE TO THIS CUSTOMER. THE REQUIREMENT FOR RIGID FIXATION OF THE REFERENCE ARRAY TO THE BONE. 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 OF PATIENT ANATOMY OF INTEREST.

    Description of Event or Problem · 1

    A MINIMALLY-INVASIVE SPINAL SURGERY FOR A STABILIZATION OF THE THORACIC SPINE (SPONDYLISTHESIS, T3-T7, EXCLUDING T5) HAS BEEN PERFORMED, WITH THE AID OF THE VIRTUAL DISPLAY BY THE BRAINLAB NAVIGATION FOR THE PLACEMENT OF THE K-WIRES FOR RESULTING PEDICLE SCREWS. INTRA-OPERATIVE CT VERIFICATION DURING THIS SURGERY REVEALED THAT 6 OUT OF 8 PLACED SCREWS WERE TILTED BY APPROX 10-15 DEGREES FROM THE INTENDED POSITIONS. THE POSITIONS OF THESE PEDICLE SCREWS WERE CORRECTED DURING THE SAME SURGERY. ACCORDING TO THE HOSPITAL (SURGEON), 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
    348265 SPINE & TRAUMA ICT; SW VERSION 1.0.2 IMAGE GUIDED SURGERY SYSTEM/STEREOT. OLO BRAINLAB AG 22180B SW VERSION 1.0.2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other