BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE & TRAUMA NAVIGATION 3.0

    MDR report key: 23495282 · Received November 7, 2025

    Report

    Report Number
    8043933-2025-00081
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    October 1, 2025
    Report Date
    November 7, 2025
    Manufacturer
    BRAINLAB SE
    Product Code
    OLO
    UDI-DI
    04056481144906
    PMA / PMN Number
    K221618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    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 PILOT HOLES AND THEIR FOLLOWING SCREWS WERE 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 2 OF THE 4 SPINE SCREWS WAS DETECTED BY THE SURGEONS WITH INTRA-OPERATIVE VERIFICATION FLUORO IMAGING BEFORE FINALIZING THE SURGERY, AND THE PLACEMENTS WERE CORRECTED UNDER FLUOROSCOPIC GUIDANCE AT THE VERY SAME SURGERY. - THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL PLACEMENTS CORRECT AT THE END OF THE SURGERY. - THERE WAS NO DIRECT (OR INCREASED) RISK TO HARM A CRITICAL ANATOMICAL STRUCTURE DUE TO THE DEVIATING PLACEMENTS. - THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING INITIAL PLACEMENTS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF 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 OF THE PILOT HOLES CREATED WITH THE AID OF NAVIGATION AND THEIR FOLLOWING SCREW PLACEMENTS IN VERTEBRAE LEFT L3 AND RIGHT L4 DEVIATING SHIFTED MAINLY CRANIALLY BY SEVERAL MM, IS: - A NOT ADEQUATE SURFACE MATCHING REGISTRATION OF THE PATIENT ANATOMY TO THE NAVIGATION BY THE USER, NOT FOLLOWING BRAINLAB INSTRUCTIONS, CAUSING THE NAVIGATION TO NOT FIND AN AS ACCURATE MATCH AS DESIRED BETWEEN THE PRE-OPERATIVE IMAGE DATASET DISPLAYED FOR INSTRUMENT LOCATION VISUALIZATION, AND THE ACTUAL PATIENT ANATOMY. NAVIGATION DATA PROVIDED FOR THIS SURGERY SHOW AN INSUFFICIENT DISTRIBUTION OF REGISTRATION POINTS COLLECTED BY THE USER ON THE VERTEBRA BONE SURFACE; THE POINTS WERE NOT ACQUIRED SUFFICIENTLY SPATIALLY DISTRIBUTED AT DIFFERENT DEPTHS AND MULTIPLE PLANES OF THE VERTEBRA SURFACE AS REQUIRED. THE DATA SHOW FURTHER THAT THE THRESHOLD OF THE CT SCAN DISPLAYED BY THE NAVIGATION FOR THE REGISTRATION WAS NOT APPROPRIATELY ADJUSTED BY THE USER TO REPRESENT A SMOOTH AND SOLID BONE SURFACE AS REQUIRED, BUT IT CONTAINED FOR E.G. (ARTIFICIAL) HOLES, WHICH SHALL BE AVOIDED AND CORRECTED WITH THE NAVIGATION FUNCTIONS BEFORE THE REGISTRATION. NAVIGATION SCREENSHOTS OF THIS PROCEDURE CORRESPONDINGLY SHOW THE NAVIGATED POINTER DEVIATING FROM THE BONE SURFACE WHEN HELD TO IT BY THE USER TO THE AFFECTED VERTEBRAE DURING THE MANDATORY NAVIGATION ACCURACY VERIFICATION OF THE REGISTRATION. APPARENTLY, DESPITE AN INACCURACY WAS VISUALIZED BY THE NAVIGATION, THE FULL EXTENT OF THE RESULTING DEVIATION BETWEEN THE ANATOMY LOCATIONS DURING THE SURGERY WAS NOT RECOGNIZED BY THE USER WITH THE NECESSARY THOROUGH NAVIGATION ACCURACY VERIFICATION OF THE REGISTRATION AND THROUGHOUT THE SURGERY, BEFORE AND DURING THE INVASIVE SPINE INSTRUMENTATIONS. 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 SPINE FOR A FUSION OF VERTEBRAE L3 AND L4, DUE TO SPONDYLOLISTHESIS, WITH INTENDED PLACEMENT OF 4 SPINE SCREWS BILATERAL, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 3.0. AFTER PLACING THE 4 SPINE SCREWS, THE SURGEONS DETERMINED FROM INTRA-OPERATIVE VERIFICATION FLUORO IMAGING THAT 2 OF THE SCREWS - IN VERTEBRAE LEFT L3 AND RIGHT L4 - DEVIATED FROM THEIR INTENDED POSITIONS SHIFTED MAINLY CRANIALLY BY SEVERAL MM AND WERE NOT IN THE PEDICLE AS DESIRED. THE DEVIATING SCREWS WERE REMOVED AND RE-PLACED TO THEIR CORRECT POSITIONS UNDER FLUOROSCOPIC GUIDANCE AT THE VERY SAME SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL PLACEMENTS CORRECT AT THE END OF THE SURGERY. - THERE WAS NO DIRECT (OR INCREASED) RISK TO HARM A CRITICAL ANATOMICAL STRUCTURE DUE TO THE DEVIATING PLACEMENTS. - THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING INITIAL PLACEMENTS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF 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
    186382 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