SPINE & TRAUMA NAVIGATION (VERSION 3.0)
Report
- Report Number
- 8043933-2025-00079
- Event Type
- Injury
- Date Received
- November 5, 2025
- Date of Event
- October 6, 2025
- Report Date
- November 25, 2025
- Manufacturer
- BRAINLAB SE
- Product Code
- OLO
- UDI-DI
- 04056481144906
- PMA / PMN Number
- K221618
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B2, H1: A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE SIX SCREWS WERE PLACED IN THE PATIENT'S SPINE IN DIFFERENT POSITIONS THAN DESIRED WITH BRAINLAB NAVIGATION INVOLVED, ALTHOUGH ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF 6 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 DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO THE DEVIATING SCREW PLACEMENTS. THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING INITIAL SCREW PLACEMENTS. THERE WERE NO FURTHER REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER. A COMPREHENSIVE INVESTIGATION BY BRAINLAB REGARDING THIS SPECIFIC EVENT IS CURRENTLY ONGOING AND FINAL CONCLUSIONS ARE PENDING. BRAINLAB PLANS TO ISSUE A FOLLOW-UP REPORT UPON COMPLETION OF THE INVESTIGATION. H6, H7: A COMPREHENSIVE INVESTIGATION BY BRAINLAB REGARDING THIS SPECIFIC EVENT IS CURRENTLY ONGOING AND FINAL CONCLUSIONS ARE PENDING. BRAINLAB PLANS TO ISSUE A FOLLOW-UP REPORT TO THE FDA UPON COMPLETION OF THE INVESTIGATION.
B2, H1: A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE 6 SCREWS (AND 8 K-WIRES) WERE PLACED IN THE PATIENT'S SPINE IN DIFFERENT POSITIONS THAN DESIRED WITH BRAINLAB NAVIGATION INVOLVED, ALTHOUGH ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF 6 SPINE SCREWS (AND 8 K-WIRES) 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 DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO THE DEVIATING SCREW PLACEMENTS. THERE WAS NO HARM OR NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE DEVIATING INITIAL SCREW PLACEMENTS. THERE WERE NO FURTHER 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 MAIN ROOT CAUSES FOR THE INITIAL DEVIATING SPINE PEDICLE SCREW PLACEMENTS PERFORMED WITH THE AID OF NAVIGATION, ARE: MOVEMENTS OF THE PATIENT REFERENCE ARRAY DURING THE SURGERY, AFTER REGISTERING THE PRE-PLACEMENT C-ARM SCAN TO THE NAVIGATION, DUE TO AN INSUFFICIENTLY RIGID FIXATION BY THE USER AND/OR INADVERTENT FORCES APPLIED TO THE ARRAY. FUSION OF THE FIRST AND SECOND NAVIGATION SCANS REVEALED A BENT SCHANZ PIN ATTACHING THE PATIENT REFERENCE ARRAY TO THE RIGHT PELVIS. ADDITIONALLY, THE SCHANZ PINS UTILIZED WERE REPORTEDLY 150MM IN LENGTH (OUTSIDE THE RECOMMENDED/TESTED 125MM) AND THE DRAPING PROCEDURE WAS OUTSIDE OF RECOMMENDATIONS WITH THE DRAPE LAYING ON TOP OF THE REFERENCE ARRAY. THIS CAUSED THE ARRAY TO BE PRONE TO INADVERTENT MOVEMENTS DUE TO FORCES APPLIED TO THE PATIENT DURING DRAPING. 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 DAMAGED DRILL GUIDE THAT CAUSED AN INACCURATE DISPLAY OF THE INSTRUMENT ON THE PATIENT ANATOMY. A BENT PIN WAS DISCOVERED ON THE ARRAY OF THE DRILL GUIDE AFTER THE SURGERY. THE INSTRUMENT WAS REPORTEDLY VALIDATED SUCCESSFULLY, ALTHOUGH DATA PROVIDED FROM THE SURGERY SHOW THAT THE VERIFICATION OF ACCURACY WAS COMPLETED VERY QUICKLY. THE DATA ALSO SHOWED THAT THE DRILL GUIDE WAS DISPLAYED INACCURATELY COMPARED TO THE POINTER WHILE PLACED WITHIN THE BONE. ADDITIONALLY, ALL OF THE K-WIRES/SCREWS PLACED WITH THE AID OF THIS NAVIGATED DRILL GUIDE DEVIATED FROM THEIR INTENDED/PLANNED POSITIONS. ADDITIONALLY, IT CAN BE CONCLUDED THAT THE MAIN ROOT CAUSE FOR THE DEVIATING PLACEMENTS DURING THE ATTEMPTED CORRECTIONS, PERFORMED WITH THE AID OF NAVIGATION, IS: THE DAMAGED DRILL GUIDE DISCUSSED ABOVE IN COMBINATION WITH THE LACK OF SURFACE AVAILABLE FOR THE DRILL GUIDE TO PROPERLY DOCK ON THE BONE LEADING TO THE DRILL GUIDE SLIPPING INTO THE PREVIOUS TRAJECTORY AND ALLOWING FOR THE FLEXIBLE K-WIRE TO FOLLOW THE PREVIOUSLY CREATED TRAJECTORY. A TO A LESSER EXTENT CONTRIBUTING FACTOR IS: RELATIVE MOVEMENTS OF THE SPINE ANATOMY DURING THE SURGERY BETWEEN THE INSTRUMENTED VERTEBRA (SPECIFICALLY L2) AND THE NAVIGATION REFERENCE ARRAY FIXATED TO THE RIGHT PELVIS, DUE TO AN INSUFFICIENTLY RIGID CONNECTION OF THE ANATOMY IN BETWEEN, AND THE FORCES APPLIED TO THE BONE DURING INSTRUMENTATION. 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. IN THIS CASE A SHIFT IN THE ANATOMY OBSERVED IN THE PROVIDED DATA (ENTIRE CONSTRUCT, INCLUDING PREVIOUSLY PLACED CAGE) THAT MATCHES THE DEVIATIONS EXPERIENCED MOST LIKELY INCREASED THE INACCURATE DISPLAY OF THE INSTRUMENT (DRILL GUIDE) DISPLAYED DURING THE UNSUCCESSFUL ATTEMPTED CORRECTIONS. 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. 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.
A MINIMALLY INVASIVE SURGERY ON THE LUMBAR SPINE FOR A LUMBAR FUSION OF VERTEBRAE L2 TO L5, WITH INTENDED PLACEMENT OF 8 SPINE SCREWS BILATERAL FOR FIXATION (AT L2, L3, L4 AND L5), 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 6 OF THE 8 SCREWS PLACED WITH THE AID OF NAVIGATION DEVIATED FROM THEIR INTENDED POSITIONS. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF 6 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 DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO THE DEVIATING SCREW PLACEMENTS. THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING INITIAL SCREW PLACEMENTS. THERE WERE NO FURTHER REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER.
A MINIMALLY INVASIVE SURGERY ON THE LUMBAR SPINE FOR A LUMBAR FUSION OF VERTEBRAE L2 TO L5, WITH INTENDED PLACEMENT OF 8 SPINE SCREWS BILATERAL FOR FIXATION (AT L2, L3, L4 AND L5), 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 6 SPINE SCREWS PLACED WITH THE AID OF NAVIGATION DEVIATED FROM THEIR INTENDED POSITIONS. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF 6 SPINE SCREWS (AND 8 K-WIRES) 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 DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO THE DEVIATING SCREW PLACEMENTS. THERE WAS NO HARM OR NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE DEVIATING INITIAL SCREW PLACEMENTS. THERE WERE NO FURTHER 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 |
|---|---|---|---|---|---|---|---|
| 5685 | SPINE & TRAUMA NAVIGATION (VERSION 3.0) | IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC | OLO | BRAINLAB SE | SW V 3.0.1 | 04056481144906 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |