SPINE & TRAUMA 3D NAVIGATION 1.5
Report
- Report Number
- 8043933-2025-00074
- Event Type
- Injury
- Date Received
- October 15, 2025
- Date of Event
- September 15, 2025
- Report Date
- October 22, 2025
- Manufacturer
- BRAINLAB SE
- Product Code
- OLO
- UDI-DI
- 04056481142025
- PMA / PMN Number
- K212245
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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 PILOT HOLES, K-WIRES AND SCREWS WERE PLACED IN THE PATIENT'S SPINE IN A DIFFERENT PATH AND POSITION THAN DESIRED WITH BRAINLAB NAVIGATION INVOLVED, DESPITE ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF THE SPINE SCREWS PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY WITH INTRA-OPERATIVE FLUORO IMAGING, AND THE PLACEMENTS WERE CORRECTED TO THEIR INTENDED POSITIONS WITH CONVENTIONAL METHODS 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 OF HARM TO A CRITICAL STRUCTURE DUE TO THE DEVIATING INITIAL PLACEMENTS. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 1-1.5HRS. 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 INITIAL SPINE SCREW PLACEMENTS WITH THE AID OF NAVIGATION, DEVIATING SHIFTED BY CA. 10-15MM CRANIALLY FROM THEIR INTENDED POSITIONS, IS A COMBINATION OF THE FOLLOWING FACTORS: MOVEMENT OF THE NAVIGATION REFERENCE ARRAY DURING THE SURGERY, AFTER REGISTERING THE PRE-PLACEMENT C-ARM SCAN TO THE NAVIGATION AND BEFORE PERFORMING THE INVASIVE SURGICAL ACTIONS IN THE SPINE, DUE TO INADVERTENT FORCES APPLIED TO EITHER THE ARRAY OR ITS FIXATION PINS BY THE USER - FOR E.G. INADVERTENT COLLISION WITH THE ARRAY UNIT. IMAGING DATA PROVIDED FOR THIS SURGERY SHOW A MOVEMENT OF THE REFERENCE ARRAY, IN BETWEEN THE PRE-PLACEMENT AND POST-PLACEMENT SCANS. FURTHER AS PER THE NAVIGATION DATA PROVIDED, THE NAVIGATION SOFTWARE DISPLAYED NAVIGATION REFERENCE ARRAY MOVEMENT WARNINGS TO THE USER DURING THE SURGERY, AT THE TIME OF THE VERIFICATION OF THE FIRST REGISTRATION AND AGAIN WHEN INSTRUMENTING LEFT L5, INDICATING THE OCCURRENCE OF ARRAY MOVEMENT. 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. MOVEMENT OF THE SPINE ANATOMY DURING THE SURGERY, RELATIVE TO THE AREA THE NAVIGATION REFERENCE ARRAY WAS FIXATED TO (LEFT PELVIS), AND THE VERTEBRAE OPERATED ON, DUE TO AN INSUFFICIENTLY RIGID CONNECTION OF THE ANATOMY IN BETWEEN AND THE FORCES APPLIED TO THE BONE DURING INSTRUMENTATION - AFFECTING MAINLY L5 AND TO ONLY A SMALL EXTENT S1. IMAGING DATA PROVIDED SHOW A SIGNIFICANT MOVEMENT OF VERTEBRA L5 (AND A SMALL MOVEMENT OF S1), IN BETWEEN THE PRE-PLACEMENT AND POST-PLACEMENT SCANS. A NOT SUFFICIENTLY RIGID ANATOMY CONNECTION TO THE ARRAY FIXATION POINT RESULTS IN RELATIVE MOVEMENTS OF THE VERTEBRAE OPERATED ON 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 OF THE ANATOMY LOCATION DISPLAYED BY THE NAVIGATION COMPARED TO THE ACTUAL PATIENT ANATOMY LOCATION DURING THE PLACEMENTS, WAS NOT RECOGNIZED BY THE USER WITH THE NECESSARY AND REQUIRED NAVIGATION ACCURACY VERIFICATION THROUGHOUT THE SURGERY, BEFORE SIGNIFICANT INVASIVE ACTIONS, AT ANY TIME FORCE WAS APPLIED TO THE BONE, AND AFTER THE WARNINGS WERE DISPLAYED BY THE NAVIGATION - THE NAVIGATION ACCURACY WAS IN GENERAL NOT SUFFICIENTLY VERIFIED BY THE USER AS NECESSARY AT THE REQUIRED OCCASIONS AT THIS SURGERY. 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.
B2, H1: A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE PILOT HOLES, K-WIRES AND SCREWS WERE PLACED IN THE PATIENT'S SPINE IN A DIFFERENT PATH AND POSITION THAN DESIRED WITH BRAINLAB NAVIGATION INVOLVED, DESPITE ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF THE SPINE SCREWS PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY WITH INTRA-OPERATIVE FLUORO IMAGING, AND THE PLACEMENTS WERE CORRECTED TO THEIR INTENDED POSITIONS WITH CONVENTIONAL METHODS 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 OF HARM TO A CRITICAL STRUCTURE DUE TO THE DEVIATING INITIAL PLACEMENTS. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 1-1.5HRS. THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS ALSO NOT PROLONGED. H6: THE DEVICE EVALUATION IS CURRENTLY ONGOING, AND RESULTS ARE PENDING. BRAINLAB INTENDS TO ISSUE A FOLLOW-UP REPORT UPON COMPLETION OF THE DEVICE EVALUATION.
A MINIMALLY INVASIVE SURGERY ON THE LUMBAR AND SACRAL SPINE, FOR A PERCUTANEOUS TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) OF VERTEBRAE L5 TO S1, WITH INTENDED PLACEMENT OF 4 SPINE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA 3D NAVIGATION 1.5. AFTER PLACING 3 OF THE 4 SCREWS - BILATERAL IN VERTEBRA L5 AND IN VERTEBRA RIGHT S1 - FROM INTRA-OPERATIVE FLUORO (X-RAY) IMAGING, THE SURGEON DETERMINED THAT THE SPINE SCREWS PLACED DEVIATED FROM THEIR INTENDED POSITIONS SHIFTED BY CA. 10-15MM CRANIALLY. THE SURGEON DECIDED TO REMOVE AND TO RE-PLACE THE DEVIATING SCREWS, AS WELL AS PLACING THE REMAINING INTENDED SCREW, WITH CONVENTIONAL METHODS UNDER FLUOROSCOPIC GUIDANCE TO THEIR CORRECT POSITIONS 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 OF HARM TO A CRITICAL STRUCTURE DUE TO THE DEVIATING INITIAL PLACEMENTS. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 1-1.5HRS. THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS ALSO NOT PROLONGED.
A MINIMALLY INVASIVE SURGERY ON THE LUMBAR AND SACRAL SPINE, FOR A PERCUTANEOUS TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) OF VERTEBRAE L5 TO S1, WITH INTENDED PLACEMENT OF 4 SPINE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA 3D NAVIGATION 1.5. AFTER PLACING 3 OF THE 4 SCREWS - BILATERAL IN VERTEBRA L5 AND IN VERTEBRA RIGHT S1 - FROM INTRA-OPERATIVE FLUORO (X-RAY) IMAGING, THE SURGEON DETERMINED THAT THE SPINE SCREWS PLACED DEVIATED FROM THEIR INTENDED POSITIONS SHIFTED BY CA. 10-15MM CRANIALLY. THE SURGEON DECIDED TO REMOVE AND TO RE-PLACE THE DEVIATING SCREWS, AS WELL AS PLACING THE REMAINING INTENDED SCREW, WITH CONVENTIONAL METHODS UNDER FLUOROSCOPIC GUIDANCE TO THEIR CORRECT POSITIONS 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 OF HARM TO A CRITICAL STRUCTURE DUE TO THE DEVIATING INITIAL PLACEMENTS. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 1-1.5HRS. 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 |
|---|---|---|---|---|---|---|---|
| 2021265 | SPINE & TRAUMA 3D NAVIGATION 1.5 | IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC | OLO | BRAINLAB SE | 22268-01C | SW V. 1.5.1 | 04056481142025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |