BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE &TRAUMA NAVIGATION 3.0

    MDR report key: 23707508 · Received December 3, 2025

    Report

    Report Number
    8043933-2025-00090
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 3, 2025
    Manufacturer
    BRAINLAB SE
    Product Code
    OLO
    UDI-DI
    04056481144906
    PMA / PMN Number
    K221618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 4 SPINE SCREWS WERE PLACED IN THE PATIENT'S SPINE IN A DIFFERENT POSITION THAN DESIRED WITH BRAINLAB NAVIGATION INVOLVED, ALTHOUGH ACCORDING TO THE HOSPITAL/SURGEON (TREATING CLINICIAN): MARK THE FOLLOWING TEXT AND PRESS F9 AGAIN TO UPDATE THE "ACCORDING TO THE HOSPITAL" SECTION: THE DEVIATION OF 4 OF THE 8 SPINE SCREWS PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY, AND THE SCREWS WERE CORRECTED TO THEIR INTENDED POSITIONS WITH NAVIGATION AT THE VERY SAME SURGERY. THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL SCREW PLACEMENTS CORRECT AT THE END OF THE SURGERY. THERE WAS NO ACTUAL HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENTS, DESPITE A DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE (PERFORATION OF DURA, SPINAL CORD). THERE WAS NO OTHER HARM OR NEGATIVE EFFECT TO THE PATIENT REPORTED, NEITHER DUE TO THE PROLONGED ANESTHESIA OF CA. 45 MINUTES, AND THERE WERE NO FURTHER MEDICAL/SURGICAL REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER. 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. H6: ACCORDING TO THE RESULTS OF THE BRAINLAB INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE MAIN ROOT CAUSE FOR THE INITIAL SPINE SCREW PLACEMENTS WITH THE AID OF NAVIGATION DEVIATING TOWARD THE PATIENTS LEFT (LEFT LATERAL, RIGHT MEDIAL) FROM THEIR INTENDED POSITIONS, IS: MOVEMENTS OF THE NAVIGATION REFERENCE ARRAY DURING THE SURGERY, AFTER REGISTERING THE PRE-PLACEMENT C-ARM SCAN TO THE NAVIGATION, AND BEFORE/WHILE PERFORMING THE INVASIVE SURGICAL ACTIONS IN THE SPINE, DUE TO AN INSUFFICIENTLY RIGID FIXATION BY THE USER AND/OR DUE TO SURGICAL OR INADVERTENT FORCES APPLIED TO THE ARRAY DURING THE PROCEDURE, (E.G. INSTRUMENTATION FORCES TRANSFERRED THROUGH THE SKIN TO THE ARRAY LOCATED AT THE APEX OF THE INCISIONS.). MULTIPLE ARRAY MOVEMENT WARNINGS WERE TRIGGERED/DISPLAYED AT THE BEGINNING/DURING THE INITIAL SCREW PLACEMENTS WITH THE ARRAY CLAMP AT THE CAUDAL PORTION OF THE INCISION. MEANING PRESSURE APPLIED TO THE SKIN VIA INSTRUMENTS/RETRACTOR COULD RESULT IN REBOUND PRESSURE AGAINST THE REFERENCE SYSTEM. NAVIGATION RECORDING DATA OF THIS SURGERY SHOW A SHIFT OF THE NAVIGATION ARRAY, CONSISTENT WITH THE DEVIATION PATTERN OBSERVED OF THE INITIAL SCREWS. 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, AND THE ACTUAL PATIENT ANATOMY. THIS MOVEMENT CANNOT BE COMPENSATED BY THE NAVIGATION SOFTWARE. A TO A LESSER EXTENT CONTRIBUTING FACTOR, ESPECIALLY FOR THE DEVIATED INITIAL PLACEMENTS AT T3 AND T4: RELATIVE MOVEMENTS OF THE SPINE ANATOMY OPERATED ON DURING THE SURGERY IN RELATION TO THE LOCATION THE NAVIGATION REFERENCE ARRAY WAS ATTACHED TO (T7), DUE TO AN INSUFFICIENTLY RIGID CONNECTION OF THE ANATOMY IN BETWEEN, AND THE FORCES APPLIED TO THE BONE DURING INSTRUMENTATION. A FRACTURE OF VERTEBRAE T5, T6, AND T7 WAS REPORTED AS THE MEDICAL INDICATION, SIGNIFICANTLY REDUCING THE RIGIDITY OF THE SPINE ANATOMY. ADDITIONALLY, A SHIFT IN THE ANATOMY WAS OBSERVED BETWEEN THE FIRST AND SECOND REGISTRATIONS WHICH INCREASED AS DISTANCE FROM THE ARRAY INCREASED, SPECIFICALLY NOTED AT T3 AND T4. MULTI-LEVEL NAVIGATION - I.E. OPERATING ON A DIFFERENT VERTEBRA THAN THE ONE THE PATIENT REFERENCE ARRAY FOR NAVIGATION IS FIXATED TO OR OPERATING ACROSS MULTIPLE VERTEBRAE WITHOUT REMOUNTING THE PATIENT REFERENCE AND REREGISTERING - ESPECIALLY IF THE CONNECTION IN BETWEEN THE VERTEBRAE IS NOT RIGID - RESULTS IN RELATIVE MOVEMENTS OF THE VERTEBRAE (ACTUAL ANATOMY) DURING THE SURGERY THAT CANNOT BE COMPENSATED BY THE NAVIGATION SOFTWARE DISPLAYING INSTRUMENT POSITIONS ON THE REGISTERED PRE-PLACEMENT PATIENT IMAGE SCAN. APPARENTLY, 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 SURGEON WITH THE APPROPRIATE AND NECESSARY NAVIGATION ACCURACY VERIFICATION THROUGHOUT THE SURGERY, AND ANY TIME SIGNIFICANT FORCE WAS APPLIED TO THE BONE, AND ADDITIONALLY DURING THE REFERENCE ARRAY MOVEMENT WARNINGS DISPLAYED, DESPITE THE SURGEON DID CHECK THE NAVIGATION ACCURACY WITH THE POINTER FOLLOWING THE WARNINGS. 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 (B)(6) 2025) ON THE THORACIC SPINE FOR A FUSION OF VERTEBRAE T3 TO T8, DUE TO A FRACTURE AT T5, T6 AND T7, WITH INTENDED PLACEMENT OF 8 SPINE SCREWS BILATERAL FOR FIXATION (AT T3, T4, T7 AND T8), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 3.0. FROM AN INTRA-OPERATIVE VERIFICATION SCAN, THE SURGEON DISCOVERED THAT OF 4 OF THE 8 SCREWS PLACED WITH THE AID OF NAVIGATION DEVIATED MEDIALLY FROM THEIR INTENDED POSITIONS (AT T3, T4, T7 AND T8 ON THE PATIENT'S RIGHT SIDE). ACCORDING TO THE HOSPITAL (DR. (B)(6), SURGEON): THE DEVIATION OF 4 OF THE 8 SPINE SCREWS PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY, AND THE SCREWS WERE CORRECTED TO THEIR INTENDED POSITIONS WITH NAVIGATION AT THE VERY SAME SURGERY. THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL SCREW PLACEMENTS CORRECT AT THE END OF THE SURGERY. THERE WAS NO ACTUAL HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENTS, DESPITE A DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE (PERFORATION OF DURA, SPINAL CORD). THERE WAS NO OTHER HARM OR NEGATIVE EFFECT TO THE PATIENT REPORTED, NEITHER DUE TO THE PROLONGED ANESTHESIA OF CA. 45 MINUTES, AND THERE WERE NO FURTHER MEDICAL/SURGICAL REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2846504 SPINE &TRAUMA NAVIGATION 3.0 IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC OLO BRAINLAB SE 22268-01G 04056481144906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other