BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINE & TRAUMA ICT NAVIGATION SOFTWARE (VERSION 1.0.2)

    MDR report key: 6332087 · Received February 15, 2017

    Report

    Report Number
    8043933-2017-00004
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    January 18, 2017
    Report Date
    January 19, 2017
    Manufacturer
    BRAINLAB AG
    Product Code
    OLO
    PMA / PMN Number
    K083310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE PEDICLE SCREWS WERE PLACED MINIMALLY INVASIVE IN THE PATIENT'S SPINE IN A DIFFERENT POSITION THAN DESIRED WITH THE BRAINLAB DEVICE INVOLVED, ALTHOUGH ACCORDING TO THE SURGEON: - THE CORRESPONDING SCREW PLACEMENTS AFTER POSITION CORRECTION AT WERE AS INTENDED, I.E. ALL SCREW POSITIONS CORRECT. - THE SURGERY WAS COMPLETED SUCCESSFULLY AS INTENDED. - THERE WERE NO NEGATIVE EFFECTS ON THE PATIENT, NEITHER DUE TO SCREW PLACEMENTS NOR PROLONG OF SURGERY/ANESTHESIA (OF CA. 4 HRS). - NO OTHER REMEDIAL ACTIONS ARE NECESSARY, DONE OR PLANNED FOR THIS PATIENT (OTHER THAN THE SCREW CORRECTION AT THE SAME SURGERY). ACCORDING TO THE RESULTS OF THE BRAINLAB INVESTIGATION AND THE INFORMATION PROVIDED BY THE SURGEON, IT CAN BE CONCLUDED THAT THE ROOT CAUSE FOR THE UNDESIRABLE SCREW POSITIONS IS A MOVEMENT OF THE NAVIGATION REFERENCE ARRAY DURING THE SURGERY (BY EXTERNAL FORCES AND NOT SUFFICIENT RIGID FIXATION), ADDITIONALLY THE REFERENCE ARRAY MOUNTED TO THE NAVIGATED TAP MIGHT HAVE MOVED DUE TO INSUFFICIENT RIGID FIXATION. APPARENTLY, THIS HAS NOT BEEN RECOGNIZED WITH THE NECESSARY CONTINUED VERIFICATION OF NAVIGATION ACCURACY BY THE USER. THERE IS NO INDICATION OF A SYSTEMATIC ERROR OR MALFUNCTION OF THE BRAINLAB DEVICE (NAVIGATION). CORRESPONDING BRAINLAB MEASURES TO MINIMIZE THIS ANTICIPATED RISK AS LOW AS REASONABLY PRACTICABLE ARE ALREADY IN PLACE. BRAINLAB INTENDS TO RE-ITERATE THE RELEVANT TOPICS REGARDING THE USE OF THE DEVICE TO THIS CUSTOMER.

    Description of Event or Problem · 1

    A MINIMALLY INVASIVE SURGERY ON THE LUMBAR SPINE FOR A FUSION OF L2-S1 (PEDICLE SCREWS PLACED IN L2 TO L5) WAS PERFORMED WITH THE AID OF THE VIRTUAL DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE&TRAUMA ICT 1.0.2. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN PRONE POSITION ON THE OR TABLE. - ATTACHED THE NAVIGATION REFERENCE ARRAY TO L2. - VERIFIED AND ACCEPTED THE AUTOMATIC REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION (TO THE INTRA-OPERATIVE CT SCAN IMPORTED INTO AND USED BY THE NAVIGATION). - PLACED THE K-WIRES WITH A NAVIGATED CALIBRATED PEDICLE ACCESS NEEDLE, AND USED A NAVIGATED CALIBRATED TAP TO PREPARE FOR THE PEDICLE SCREWS. - PLACED THE PEDICLE SCREWS INTO THE PREPARED TAPPED HOLES ON BOTH SIDES L2 TO L5 WITH A NON-NAVIGATED SCREWDRIVER. - VERIFIED THE PLACEMENTS OF SCREWS WITH ANOTHER INTRA-OP CT SCAN. - DETERMINED THE SCREWS ON THE LEFT SIDE AND ONE SCREW ON THE RIGHT WERE NOT PLACED AS INTENDED (DEVIATIONS IN BETWEEN CA. 5 MM AND 8.5 MM) - RE-PLACED THESE SCREWS (ADJUSTED POSITION) DURING THE SAME SURGERY USING A NEW INTRA-OP CT SCAN WITH AUTOMATIC REGISTRATION WITH NAVIGATION AND X-RAY. THE CORRESPONDING SCREW PLACEMENTS AFTER POSITION CORRECTION WERE AS INTENDED. - COMPLETED THIS SURGERY SUCCESSFULLY AS INTENDED. ACCORDING TO THE SURGEON: - THE CORRESPONDING SCREW PLACEMENTS AFTER POSITION CORRECTION AT WERE AS INTENDED, I.E. ALL SCREW POSITIONS CORRECT. - THE SURGERY WAS COMPLETED SUCCESSFULLY AS INTENDED. - THERE WERE NO NEGATIVE EFFECTS ON THE PATIENT, NEITHER DUE TO SCREW PLACEMENTS NOR PROLONG OF SURGERY/ANESTHESIA (OF CA. 4 HRS). - NO OTHER REMEDIAL ACTIONS ARE NECESSARY, DONE OR PLANNED FOR THIS PATIENT (OTHER THAN THE SCREW CORRECTION AT THE SAME SURGERY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116098 SPINE & TRAUMA ICT NAVIGATION SOFTWARE (VERSION 1.0.2) IMAGE GUIDED SURGERY SYSTEM/STEREOTAXIC OLO BRAINLAB AG 22180B SW VERSION 1.0.2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other