BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE & TRAUMA NAVIGATION 3.0

    MDR report key: 24966058 · Received April 23, 2026

    Report

    Report Number
    8043933-2026-00025
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    April 8, 2026
    Report Date
    April 23, 2026
    Manufacturer
    BRAINLAB SE
    Product Code
    OLO
    UDI-DI
    04056481144906
    PMA / PMN Number
    K221618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2, H1: A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE A PILOT HOLE AND SCREW WAS PLACED IN THE PATIENT'S SPINE IN A DIFFERENT POSITION THAN DESIRED WITH NAVIGATION INVOLVED, DESPITE ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF THE FIRST SPINE SCREW PLACED WAS DETECTED BY THE SURGEON WITH INTRA-OPERATIVE C-ARM IMAGING DIRECTLY AFTER ITS PLACEMENT, AND THE SCREW PLACEMENT WAS CORRECTED TO ITS INTENDED POSITION AT THE VERY SAME SURGERY WITH NAVIGATION. THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL SPINE SCREW PLACEMENTS CORRECT AT THE END OF THE SURGERY. THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THIS PLACEMENT'S DEVIATION. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT RESULTING DUE TO THE DEVIATING PLACEMENT, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF MAXIMUM CA. 30MIN. THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS ALSO NOT PROLONGED. H6: ACCORDING TO THE RESULTS OF THE BRAINLAB INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE ROOT CAUSE FOR THE SPINE PILOT HOLE AND SCREW PLACED WITH THE AID OF NAVIGATION IN LEFT S1 DEVIATING SHIFTED SUPERIORLY AND INTO THE DISC SPACE, IS: MOVEMENTS OF THE NAVIGATION REFERENCE ARRAY DURING THE SURGERY ON THE PATIENT ANATOMY, AFTER REGISTERING THE PRE-PLACEMENT C-ARM SCAN TO THE NAVIGATION, AND BEFORE PERFORMING THE AFFECTED INVASIVE ACTIONS IN THE SPINE, DUE TO A NOT SUFFICIENTLY RIGID ARRAY FIXATION TO THE BONE BY THE USER AS REQUIRED, MAKING IT PRONE TO MOVEMENTS BY ANY SURGICAL FORCES APPLIED DURING THE SURGERY, AND INADVERTENT FORCES APPLIED TO THE ARRAY DURING THE PROCEDURE. IMAGING DATA PROVIDED FOR THIS SURGERY SHOW THE REFERENCE ARRAY UNIT WAS INADVERTENTLY FIXATED IN BETWEEN THE SPINOUS PROCESSES OF VERTEBRAE L5 AND S1, ON THE MARGIN OF THE S1 SPINOUS PROCESS (ON LIGAMENTS) INSTEAD OF FULLY ON THE SPINOUS PROCESS. IN ADDITION, THE ARRAY WAS FIXATED AT THE CAUDAL MARGIN OF THE INCISION IN CONTACT WITH THE SKIN, ALLOWING SURGICAL OR INSTRUMENT FORCES BEING TRANSFERRED TO THE ARRAY UNIT VIA SAID SKIN TISSUE. FURTHER NAVIGATION DATA SHOW A SIGNIFICANT POSITION CHANGE OF THE REFERENCE ARRAY AND THAT CORRESPONDING REFERENCE ARRAY MOVEMENT WARNINGS WERE DISPLAYED BY THE NAVIGATION, AT THE TIME OF THE AFFECTED PLACEMENT. MOVEMENT OF THE REFERENCE ARRAY AFTER PATIENT REGISTRATION TO NAVIGATION DISRUPTS THE COORDINATE SYSTEM ESTABLISHED DURING THE REGISTRATION AND CAUSES A DEVIATION BETWEEN THE DISPLAYED IMAGE SCAN, ON WHICH THE NAVIGATED INSTRUMENTS ARE TRACKED FOR POSITION VISUALIZATION, AND THE ACTUAL PATIENT ANATOMY. THIS MOVEMENT CANNOT BE COMPENSATED BY THE NAVIGATION SOFTWARE. APPARENTLY, DESPITE THE USER RE-VERIFIED THE NAVIGATION ACCURACY AFTER THE ARRAY MOVEMENT WARNINGS WERE DISPLAYED, THE RESULTING DEVIATION BETWEEN THE LOCATIONS OF THE ACTUAL PATIENT ANATOMY AND THE REGISTERED PRE-PLACEMENT PATIENT IMAGE SCAN DISPLAYED BY THE NAVIGATION DURING THE SURGERY WAS NOT RECOGNIZED BY THE USER FOR THE AFFECTED SPINE PLACEMENT - ALTHOUGH THE USER DETECTED AND ADDRESSED IT BEFORE THE NEXT INTENDED PLACEMENT - WITH THE APPROPRIATE AND NECESSARY NAVIGATION ACCURACY VERIFICATION THROUGHOUT THE SURGERY, AND ANY TIME SIGNIFICANT FORCE WAS APPLIED TO THE BONE. 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. H7: BRAINLAB INTENDS TO RE-ITERATE THE RELEVANT TOPICS REGARDING THE USE OF THE DEVICE TO THIS CUSTOMER.

    Description of Event or Problem · 0

    AN OPEN SURGERY ON THE LUMBAR AND SACRAL SPINE FOR AN EXTENSION FUSION OF VERTEBRAE L5 AND S1, DUE TO SPONDYLOLISTHESIS AT THESE VERTEBRAE, WITH INTENDED PLACEMENT OF 2 SPINE SCREWS BILATERAL, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 3.0. AFTER PLACING THE FIRST SCREW IN VERTEBRA LEFT S1, THE SURGEON DETECTED THAT THE NAVIGATION ACCURACY HAD DECREASED, AND DETERMINED FROM INTRA-OPERATIVE C-ARM IMAGING, THAT THE LEFT S1 SCREW DEVIATED FROM ITS INTENDED POSITION SHIFTED SUPERIORLY AND INTO THE DISC SPACE. THE SURGEON DECIDED TO REMOVE THE DEVIATING SCREW AND TO RE-PLACE IT WITH NAVIGATION TO ITS CORRECT POSITION AT THE VERY SAME SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL SPINE SCREW PLACEMENTS CORRECT AT THE END OF THE SURGERY. THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THIS PLACEMENT'S DEVIATION. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT RESULTING DUE TO THE DEVIATING PLACEMENT, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF MAXIMUM CA. 30MIN. THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS ALSO NOT PROLONGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304161 SPINE & TRAUMA NAVIGATION 3.0 IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC OLO BRAINLAB SE 22268-04C SW V. 3.0.2 04056481144906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other