BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5)

    MDR report key: 18806228 · Received February 29, 2024

    Report

    Report Number
    8043933-2024-00013
    Event Type
    Injury
    Date Received
    February 29, 2024
    Date of Event
    February 5, 2024
    Report Date
    February 29, 2024
    Manufacturer
    BRAINLAB AG
    Product Code
    OLO
    UDI-DI
    04056481142025
    PMA / PMN Number
    K212245
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 SCREWS WERE PLACED IN THE PATIENT'S SPINE IN A DIFFERENT POSITION THAN DESIRED WITH NAVIGATION INVOLVED, ALTHOUGH ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF 2 OF THE 4 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 WITHOUT 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 NEITHER HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING SPINE SCREWS, ALSO NOT DUE TO THE PROLONGED ANESTHESIA OF CA. 30 MINUTES. - THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER. H6: ACCORDING TO THE RESULTS OF THE BRAINLAB INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE ROOT CAUSES OF THE DEVIATED SPINE SCREWS PLACED BILATERALLY AT VERTEBRA L5, SHIFTED CAUDALLY BY AN ESTIMATED CA. 5 MM, ARE: - MOVEMENT OF THE PATIENT REFERENCE ARRAY DUE TO INCORRECT AND UNINTENDED REFERENCE CLAMP ATTACHMENT. ACCORDING TO THE IMAGING DATA PROVIDED BY THE HOSPITAL FOR THIS SURGERY, THE REFERENCE CLAMP WAS NEITHER ATTACHED SECURELY TO THE BONE, NOR WAS IT LOCATED IN THE INTENDED/REPORTED VERTEBRA, L4. IN THIS CASE, THE REFERENCE CLAMP WAS ATTACHED TO THE CAUDAL END OF THE L3 SPINOUS PROCESS AND EXTENDED INTO THE TISSUE BETWEEN THE L3 AND L4 SPINOUS PROCESSES. THIS PLACEMENT REDUCED STABILITY OF THE REFERENCE CLAMP AND ARRAY MAKING IT MORE PRONE TO INADVERTENT MOVEMENTS DUE TO, FOR EXAMPLE, SKIN PRESSURE/REBOUND. IN THE 3D RECONSTRUCTION OF THE DATA SET, THE REFERENCE CLAMP IS OBSERVED TO HAVE BEEN IN CONTACT WITH PATIENT SKIN DURING THE SCAN. IF AFTERWARDS THE SKIN WAS MOVED, THE PRESSURE ON THE PATIENT REFERENCE ARRAY WOULD HAVE CHANGED AND IT WOULD HAVE BEEN DISPLACED, MAKING THE REGISTRATION AND SUBSEQUENT NAVIGATION INACCURATE. - RELATIVE MOVEMENTS OF THE SPINE ANATOMY DURING THE SURGERY BETWEEN THE VERTEBRA THE NAVIGATION REFERENCE ARRAY WAS FIXATED TO (L3), AND THE VERTEBRAE OPERATED ON DUE TO A NON-RIGID CONNECTION OF THE ANATOMY IN BETWEEN, AND THE FORCES APPLIED TO THE BONE DURING INSTRUMENTATION. A STRUCTURAL INSTABILITY (SPONDYLOLISTHESIS BETWEEN L4 AND L5) WAS PRESENT WITH THIS PATIENT, WHICH REDUCES THE RIGIDITY OF THE SPINE, AND THE OPENING OF THE CORTICAL BONE BY MALLETING THE TAP APPLIES CONSIDERABLE FORCES ON THE VERTEBRAE. 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. THE EFFECT OF THE RELATIVE MOMENTS INCREASES WITH INCREASING DISTANCE FROM THE VERTEBRA WHERE THE PATIENT REFERENCE ARRAY IS FIXATED. ANOTHER CONTRIBUTING FACTOR IS: - INSTRUMENTATION ON THE PATIENT ANATOMY WITH A NAVIGATED TAP AND SCREWDRIVER WHICH FAILED ACCURACY CHECKS DURING CALIBRATION. THE CALIBRATION PROCEDURE OF THESE INSTRUMENTS RESULTED IN ACCURACY WARNINGS. HOWEVER, THE USER CHOSE TO PROCEED WITH THE VERIFICATION STEP OF INSTRUMENT CALIBRATION AND APPROVE THEM. POTENTIAL CALIBRATION INACCURACIES ARISING FROM THIS COULD HAVE LED TO INSTRUMENT TRACKING ERRORS WHICH MAY HAVE CONTRIBUTED TO THE DEVIATING SPINE SCREW PLACEMENTS OBSERVED IN L5. APPARENTLY, THE RESULTING DEVIATION OF THE REGISTERED PREOPERATIVE PATIENT IMAGE DISPLAYED BY THE NAVIGATION AND THE ACTUAL PATIENT ANATOMY WAS NOT DETECTED BY THE USER WITH THE NECESSARY ACCURACY VERIFICATION AFTER REGISTRATION. WITHOUT CONSISTENT VERIFICATION OF ACCURACY THROUGHOUT THE PROCEDURE, THIS INACCURACY WOULD NOT BE DISCOVERED. 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 LAMINECTOMIES AND FUSION OF VERTEBRAE L4-5, DUE TO SPONDYLOLISTHESIS, WITH INTENDED PLACEMENT OF AN INTERBODY CAGE AND 4 SPINE SCREWS BILATERALLY FOR FIXATION (AT L4-5), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA 3D NAV 1.5. DURING THE PROCEDURE THE SURGEON: - WITH THE PATIENT IN PRONE POSITION ACQUIRED A C-ARM SCAN TO LOCALIZE AND MAKE A MEDIAL INCISION AT THE REGION OF INTEREST. - PERFORMED LAMINECTOMIES AT L4 AND L5 THROUGH THE MEDIAL INCISION BEFORE PLACING AN INTERBODY CAGE BETWEEN THOSE VERTEBRAE. - ATTACHED THE NAVIGATION REFERENCE ARRAY TO THE CAUDAL END OF THE L3 SPINOUS PROCESS AND THE TISSUE BETWEEN L3 AND L4 SPINOUS PROCESSES. - ACQUIRED AN INTRA-OPERATIVE 3D C-ARM SCAN OF THE PATIENT'S REGION OF INTEREST WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION. - VERIFIED THE REGISTRATION AND ACCEPTED THE ACCURACY TO PROCEED. - USED A BRAINLAB POINTER TO DETERMINE THE LOCATION FOR SCREWS TO BE PLACED ON THE PATIENT'S LEFT SIDE AND MADE A LEFT LATERAL INCISION. - CALIBRATED A NON-BRAINLAB TAP TO THE NAVIGATION FOR INSTRUMENT POSITION DISPLAY ON THE PATIENT SCAN, NAVIGATED IT TO THE PEDICLE AT LEFT L4, MALLETED IT INTO PLACE, CREATING A PILOT HOLE, AND SAVED THE SCREW TRAJECTORY. - CALIBRATED A NON-BRAINLAB SCREWDRIVER TO THE NAVIGATION AND ALIGNED THE TIP OF THE SCREW TO THE SAVED TRAJECTORY AT THE PILOT HOLE. - REMOVED THE SCREW FROM THE PILOT HOLE AT LEFT L4 BECAUSE HE NO LONGER APPROVED OF THE INITIAL TRAJECTORY. - REPEATED THE NAVIGATED APPROACH TO CREATE A NEW TRAJECTORY AND PILOT HOLE AT LEFT L4 AND SECURED THE SCREW IN THE SPINE. - MAINTAINED THE NAVIGATED APPROACH TO PLACE THE SCREW AT LEFT L5. - SWITCHED HIS STANDING POSITION FROM THE PATIENT'S LEFT TO THEIR RIGHT SIDE AND MAINTAINED THE NAVIGATED APPROACH TO MAKE A LATERAL INCISION ON THE RIGHT SIDE AND PLACE SCREWS AT RIGHT L4-5. - ACQUIRED AN X-RAY SCAN TO VERIFY THE SCREW PLACEMENTS. - DETERMINED THAT OF 2 OF THE 4 SCREWS PLACED WITH THE AID OF NAVIGATION DEVIATED FROM THEIR INTENDED POSITIONS (AT L5, DEVIATING BY CA. 5 MM CAUDALLY FROM THEIR INTENDED POSITIONS). -DECIDED TO REMOVE THE DEVIATING SPINE SCREWS AND RE-PLACED THEM AT THEIR CORRECT POSITIONS WITHOUT THE AID OF NAVIGATION (USING FLUOROSCOPY). - COMPLETED THE SURGERY SUCCESSFULLY AS INTENDED AND CLOSED THE PATIENT. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF 2 OF THE 4 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 WITHOUT 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 NEITHER HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING SPINE SCREWS, ALSO NOT DUE TO THE PROLONGED ANESTHESIA OF CA. 30 MINUTES. - THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224730 SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC OLO BRAINLAB AG 22268-01C SW V. 1.5.1 04056481142025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other