Spine & Trauma Navigation 2.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 04056481143954), received between Jan 27, 2023 and Mar 21, 2026 — classified as 102 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (98 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 102 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2026Use of Device Problem; Improper or Incorrect Procedure or Method

  AN OPEN SURGERY ON THE THORACIC SPINE, FOR A STABILIZATION FROM T8 TO T10 WITH OMISSION OF T9 AND WITH AN ADDITIONAL LAMINECTOMY AND TUMOR RESECTION AFTER STABILIZATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION (SPINE & TRAUMA NAVIGATION 2.0.0). THE SURGEON DETERMINED FROM AN INTRA OPERATIVE SCAN THAT TWO OUT OF FOUR SPINE SCREWS PLACED - AT T8 RIGHT AND T10 RIGHT - DEVIATED FROM THEIR INTENDED POSITIONS BY APPROX. 2MM MEDIALLY. THE SURGEON DECIDED TO REMOVE AND RE-PLACE THE DEVIATING SPINE SCREWS TO THEIR CORRECT POSITIONS DURING THE VERY SAME SURGERY USING NAVIGATION. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL SCREW PLACEMENTS CORRECT AT THE SAME SURGERY. THERE WAS AN INCREASED RISK OF HARM AND A TEMPORARY, MINOR, REVERSIBLE SENSORY DEFICIT POSTOPERATIVELY, POSSIBLY RELATED TO THE INITIAL MALPOSITION, THERE WAS NO FURTHER HARM NOR NEGATIVE EFFECT TO THE PATIENT RESULTING, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 60MIN. THERE WERE NO FURTHER REMEDIAL ACTIONS NEEDED, PLANNED, OR PERFORMED AFTER THE SURGERY. HOSPITALIZATION WAS NOT PROLONGED.

  Patient problems: Hypoesthesia

  MAUDE report 24656651 ↗
• InjuryFeb 2, 2026Use of Device Problem

  AN OPEN SURGERY ON THE THORACIC, LUMBAR AND SACRAL SPINE, FOR A THORACO-LUMBAR FUSION FROM VERTEBRA T4 TO THE PELVIS, DUE TO SPINAL DEFORMITY IN THIS AREA, WITH INTENDED PLACEMENT OF 32 SPINE SCREWS - INCLUDING 2 S2AI SCREWS, AND 2 HOOKS AT VERTEBRA T4 - BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 2.0. AFTER DRILLING THE FIRST PILOT HOLE FOR THE HOOK IN VERTEBRA RIGHT T4, DETECTED THAT IT DEVIATED LATERALLY FROM ITS INTENDED POSITION AND PLACED THE HOOK STILL. AFTER CONTINUING TO PLACE THE SPINE SCREW IN VERTEBRA RIGHT T5, DETERMINED THIS SCREW PLACEMENT ALSO DEVIATED LATERALLY, AND CONFIRMED THE DEVIATION WITH AN INTRA-OPERATIVE CT SCAN. THE SURGEON DECIDED TO REMOVE THE DEVIATING SCREW IN T5, AND TO RE-PLACE IT TO ITS CORRECT POSITION WITH NAVIGATION, USING THE VERIFICATION CT SCAN. AFTER CONTINUING TO PLACE THE SPINE SCREWS BILATERAL IN VERTEBRAE T5 TO T12, THE SURGEON DETERMINED FROM ANOTHER INTRA-OPERATIVE VERIFICATION CT SCAN, THAT 3 OF THE SCREWS - IN VERTEBRAE LEFT T9 TO T11 - DEVIATED MEDIALLY, AND DECIDED TO REMOVE THESE 3 SCREWS AT THIS SURGERY WITHOUT RE-PLACING THEM. THE MAGNITUDE OF THE DEVIATION OF THE SCREWS ESTIMATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232553 ↗
• InjuryDec 19, 2025Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  AN OPEN SURGERY ON THE LUMBAR SPINE FOR FUSION OF VERTEBRAE (L2-L5), WITH INTENDED PLACEMENT OF 6 BILATERAL SCREWS WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 2.0. FROM AN INTRA-OPERATIVE 2D SCAN, THE SURGEON DISCOVERED THE 6 SPINE SCREWS PLACED WITH THE AID OF NAVIGATION DEVIATED FROM THEIR INTENDED POSITIONS. THE DEVIATING SCREWS WERE REMOVED AND RE-PLACED TO THEIR INTENDED POSITIONS CONVENTIONALLY WITHOUT NAVIGATION AT THE VERY SAME SURGERY. ACCORDING TO THE LIMITED INFORMATION FROM THE HOSPITAL/SURGEON (TREATING CLINICIAN): - THE DEVIATION OF 6 SPINE SCREWS PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY AND WERE CORRECTED TO THEIR INTENDED POSITION WITHOUT NAVIGATION AT THE VERY SAME SURGERY. - THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT REPORTED DUE TO THE INITIAL DEVIATING SCREW PLACEMENTS, NEITHER DUE TO THE PROLONGED ANESTHESIA OF 45-60 MINUTES. - NO REMEDIAL ACTIONS FOR THE PATIENT WERE REPORTED THAT WOULD HAVE BEEN DONE, NECESSARY OR PLANNED, NOR WAS PROLONGATION OF HOSPITALIZATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849910 ↗
• InjuryDec 18, 2025Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839041 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A MINIMALLY INVASIVE SURGERY ON THE LUMBAR SPINE, WITH INTENDED PLACEMENT OF 8 SPINE SCREWS BILATERAL FOR FIXATION (AT L1, L2, L3 AND L4), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 2.0. FROM AN INTRA-OPERATIVE VERIFICATION SCAN, THE SURGEON DISCOVERED THAT OF 2 OF THE 8 SCREWS, PLACED BILATERALLY AT L4, DEVIATED LATERALLY FROM THEIR INTENDED POSITIONS. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF 2 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 POSITION 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 PLACEMENTS. - THERE WAS NEITHER HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING INITIAL PLACEMENTS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 30 MINUTES. - THERE WERE NO FURTHER REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654820 ↗
• InjuryNov 19, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A MINIMALLY INVASIVE SURGERY ON THE LUMBAR SPINE FOR A FUSION OF VERTEBRAE L2 TO L4, DUE TO OSTEOPOROSIS/ DEGRADATION AT L3, WITH INTENDED PLACEMENT OF 6 K-WIRES BILATERAL (AT L2, L3 AND L4) FOR SUBSEQUENT SPINE SCREW PLACEMENT, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 2.0. FROM AN INTRA-OPERATIVE CT SCAN, THE SURGEON DISCOVERED THE 6 K-WIRES PLACED WITH THE AID OF NAVIGATION DEVIATED FROM THEIR INTENDED POSITIONS. THE DEVIATING K-WIRES WERE REMOVED AND RE-PLACED TO THEIR INTENDED POSITIONS WITH NAVIGATION AT THE VERY SAME SURGERY, BEFORE PLACING THEIR SUBSEQUENT SPINE SCREWS. ACCORDING TO THE LIMITED INFORMATION PROVIDED BY THE HOSPITAL (TREATING CLINICIAN): THE DEVIATION OF 6 K-WIRES PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY, AND THE K-WIRES WERE CORRECTED TO THEIR INTENDED POSITION 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 REPORTED DUE TO THE DEVIATING PLACEMENTS AS WELL AS NO HAR

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23591876 ↗
• InjuryNov 11, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A MINIMALLY INVASIVE SURGERY ON THE THORACIC AND LUMBAR SPINE FOR A FUSION OF VERTEBRAE T10 TO L2, DUE TO FRACTURE AT T11 AND T12, WITH INTENDED PLACEMENT OF 8 VERTEBRA SCREWS BILATERAL FOR FIXATION (AT T10, T11, L1 AND L2), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 2.0. FROM AN INTRA-OPERATIVE SCAN, THE SURGEON DISCOVERED THAT 2 OF THE 8 SCREWS PLACED WITH THE AID OF NAVIGATION DEVIATED FROM THEIR INTENDED POSITIONS AT LEFT AND RIGHT T10. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF 2 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 A DIRECT / AN INCREASED RISK OF HARM TO A CRITICAL STRUCTURE (BLOOD VESSELS - A T10 SEGMENTAL ARTERY) DUE TO THE REPORTED PROBLEM. THE PATIENT EXPERIENCED A HIGH AMOUNT OF BLOOD LOSS AND A HEMOTHORAX AND REQUIRED FURTHER INTERVENTIONS TO REVERT A SERIOUS DETERIORATION OF HEALTH (C

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hemothorax

  MAUDE report 23523518 ↗
• InjuryNov 11, 2025Use of Device Problem; Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE LUMBAR SPINE FOR A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) OF VERTEBRAE L3 AND L4, INCLUDING A CAGE PLACEMENT, WITH INTENDED PLACEMENT OF 4 SPINE SCREWS BILATERAL, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SPINE & TRAUMA NAVIGATION 2.0. FROM AN INTRA-OPERATIVE C-ARM SCAN, THE SURGEON DETECTED THAT THE SPINE SCREWS PLACED BILATERAL IN L3 AND L4 DEVIATED FROM THEIR INTENDED POSITIONS SHIFTED BY CA. 6MM TO THE LEFT, WITH THE RIGHT SIDED SCREWS INTO THE SPINAL CANAL. THE SURGEON DECIDED TO REMOVE THE SCREWS AND TO RE-PLACE THEM TO THEIR CORRECT POSITIONS WITH NAVIGATION AT THE VERY SAME SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): NON-REMOVAL / NON-REPLACEMENT OF THE DEVIATING SCREWS PLACED INTO THE SPINAL CANAL WOULD HAVE EXPECTEDLY LED TO A CRITICAL HARM TO THE PATIENT, BY IRRITATING THE SPINAL NERVES EXPECTEDLY LEADING TO SENSORY OR MOTOR DEFICITS IN THE LONG TERM. THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL PLACEMENTS CORRECT AT THE END OF THE SURGERY. THERE WAS NO ACTUAL HARM/NEGATIVE CLINICAL EFFECT TO THE PATIENT RESULTING DUE TO THE DEVIATING PLACEMENTS, ALSO NOT DUE TO THE PROLONGATION OF THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520776 ↗
• InjuryOct 31, 2025Use of Device Problem; Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE THORACIC SPINE FOR A PERCUTANEOUS STABILIZATION OF VERTEBRAE T4 AND T5, DUE TO SPONDYLARTHRITIS, WITH INTENDED PLACEMENT OF 4 SPINE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SOFTWARE SPINE & TRAUMA NAVIGATION 2.0. FROM AN INTRA-OPERATIVE VERIFICATION CT SCAN, THE SURGEON DETERMINED THAT 4 K-WIRES PLACED WITH THE AID OF NAVIGATION AT T4 AND T5 DEVIATED BY CA. 4MM FROM THEIR INTENDED POSITIONS, WITH THE LEFT SIDE K-WIRES BEING PLACED INTO THE SPINAL CANAL. THE DEVIATING K-WIRES WERE REMOVED AND RE-PLACED TO THEIR INTENDED POSITIONS WITH NAVIGATION AT THE VERY SAME SURGERY, BEFORE PLACING THEIR SUBSEQUENT SPINE SCREWS. ACCORDING TO THE HOSPITAL (PHYSICIAN, CLINICIAN): - THE DEVIATION OF 4 K-WIRES PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON WITH AN INTRA-OPERATIVE VERIFICATION CT SCAN, AND THE K-WIRES WERE CORRECTED TO THEIR INTENDED POSITIONS WITH NAVIGATION AT THE VERY SAME SURGERY, BEFORE PLACING THEIR SUBSEQUENT SPINE SCREWS. - THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL PLACEMENTS CORRECT AT THE END OF THE SURGERY. - THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436925 ↗
• InjuryOct 24, 2025Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE THORACIC SPINE FOR A T7-T11 POSTERIOR SPINAL FUSION, AND T9 CORPECTOMY DUE TO A FRACTURE/INFECTION AT T9, WITH INTENDED PLACEMENT OF 8 SPINE SCREWS BILATERAL FOR FIXATION (AT T7, T8, T10 AND T11), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 2.0. FROM INTRA-OPERATIVE FLUOROSCOPIC IMAGES , THE SURGEON DISCOVERED THAT 4 OF THE 8 SCREWS, PLACED AT T7 - T8, WITH THE AID OF NAVIGATION (SPECIFICALLY DURING THE CREATION OF PILOT HOLES), DEVIATED CRANIALLY FROM THEIR INTENDED POSITIONS. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF 4 OF THE 8 PEDICLE SCREWS 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 NO ACTUAL HARM OR NEGATIVE EFFECT ON THE PATIENT DUE TO THE UNINTENDED SURGICAL STEPS PERFORMED WITH THE AID OF NAVIGATION. - THERE WAS NO HARM OR NEGATIVE EFFECT ON THE PATIENT REPORTED DUE TO THE PROLONGED ANESTHESIA OF CA. 15 MINUTES. - NO F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379047 ↗
• InjuryOct 15, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  AN OPEN SURGERY ON THE CERVICAL SPINE FOR FUSION OF VERTEBRAE C3 - C4 WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SOFTWARE SPINE & TRAUMA NAVIGATION 2.0. FROM AN INTRA-OPERATIVE CONFIRMATION SCAN, THE SURGEON DETERMINED THAT ONE SPINE SCREW PLACED IN VERTEBRA C3, WITH THE AID OF NAVIGATION, DEVIATED FROM ITS INTENDED POSITION. THE MISPLACED SCREW WAS REPORTEDLY REMOVED AND REPLACED DURING THE SAME SURGERY. FURTHER DETAILS OF THE EFFECTS ON THE PATIENT COULD NOT YET BE RETRIEVED FROM THE HOSPITAL. BRAINLAB CONTINUES TO FOLLOW UP WITH THE HOSPITAL.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289421 ↗
• InjurySep 2, 2025Use of Device Problem; Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE THORACIC AND LUMBAR SPINE FOR A FUSION OF VERTEBRAE T7 TO T10 AND T12 TO L2, INCL. CEMENT AUGMENTATION, DECOMPRESSION OF THE SPINAL CORD AT T9/T10, AND DEBULKING OF A TUMOR, WITH INTENDED PLACEMENT OF 14 VERTEBRA SCREWS BILATERAL, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SPINE & TRAUMA NAVIGATION 2.0. FROM INTRA-OPERATIVE C-ARM SCANS, THE SURGEON DETECTED THAT THE SPINE SCREWS PLACED BILATERAL IN VERTEBRAE T7 TO T9 DEVIATED FROM THEIR INTENDED POSITIONS SHIFTED BY MAX. 5MM TO THE LEFT, AND SOME OF THEM INTO THE SPINAL CANAL. THE SURGEON DECIDED TO REMOVE THESE SCREWS AND TO RE-PLACE THEM TO THEIR CORRECT POSITIONS WITH NAVIGATION AT THE VERY SAME SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): NON-REMOVAL / NON-REPLACEMENT OF THESE DEVIATING SCREWS WOULD HAVE EXPECTEDLY LED TO A CRITICAL HARM TO THE PATIENT, RISKING NEUROLOGICAL COMPLICATIONS DUE TO THE SCREWS DAMAGING THE SPINAL CORD. THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL PLACEMENTS CORRECT AT THE END OF THE SURGERY. THERE WAS NO ACTUAL HARM/NEGATIVE CLINICAL EFFECT TO THE PATIENT RESULTING DUE TO THE DEVIATING PLACEMENTS, ALSO NOT DUE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931763 ↗
• InjuryJul 23, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  AN OPEN SURGERY (ON (B)(6) 2025) FOR EXTREME LATERAL INTERBODY FUSION (XLIF) FROM L2 TO S1 WITH POSTERIOR FUSION FROM L3 TO L5 WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 2.0.1. DURING THE PROCEDURE, THE SURGEON DISCOVERED THAT K-WIRES ON LEVELS L3-L5 PLACED WITH THE AID OF NAVIGATION DEVIATED FROM THEIR INTENDED POSITION. ACCORDING TO THE HOSPITAL (BASED ON INFORMATION RECEIVED AT THIS POINT OF TIME - FOLLOW-UP TO OBTAIN FURTHER DETAILS IS ONGOING): - AFTER THE DETECTION OF THE MISPLACED K-WIRES THE SURGEON COMPLETED THE SURGERY CONVENTIONALLY WITHOUT AID OF NAVIGATION - THERE WAS NO ACTUAL HARM/NEGATIVE CLINICAL EFFECT TO THE PATIENT REPORTED DUE TO THE MISPLACED K-WIRES - THERE WERE NO FURTHER MEDICAL/SURGICAL REMEDIAL ACTIONS REPORTED THAT WOULD HAVE BEEN NECESSARY, DONE OR PLANNED FOR THIS PATIENT DUE TO THE MISPLACED K-WIRES, NOR WAS A PROLONGATION OF HOSPITALIZATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574433 ↗
• InjuryJul 15, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  AN OPEN SURGERY ON THE LUMBAR SPINE FOR A LUMBAR FUSION OF VERTEBRAE L3 TO L4 AND DECOMPRESSION, WITH INTENDED PLACEMENT OF 4 SPINE SCREWS BILATERAL FOR FIXATION (AT L3 AND L4), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 2.0. FROM AN INTRA-OPERATIVE SCAN, THE SURGEON DISCOVERED THAT OF 1 OF THE 4 SCREWS PLACED WITH THE AID OF NAVIGATION DEVIATED FROM ITS INTENDED POSITION (AT RIGHT L3, DEVIATING MEDIALLY BY 5 MM). ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF 1 OF THE 4 SPINE SCREWS PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY, AND THE SCREW WAS CORRECTED TO ITS INTENDED POSITION 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 NO ACTUAL HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENT, DESPITE A DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO THE DEVIATING PLACEMENT (SCREW WENT INTO THE SPINAL CANAL). THERE WERE NO FURTHER REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22507707 ↗
• InjuryJul 10, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A MINIMALLY INVASIVE SURGERY (ON (B)(6) 2025) ON THE LUMBAR SPINE FOR A FUSION OF VERTEBRAE L4 TO L5, USING A PRONE LATERAL APPROACH FOR CAGE INSERTION, WITH INTENDED PLACEMENT OF 4 SPINE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 2.0. FROM POST-OPERATIVE SCANS TAKEN THE NEXT MORNING, THE SURGEON DISCOVERED THAT THE RIGHT L5 SCREW PLACED WITH THE AID OF NAVIGATION DEVIATED FROM THEIR INTENDED POSITION. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF 1 OF 4 SPINE SCREWS PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON AFTER THE SURGERY, AND THE SCREW WAS CORRECTED TO ITS INTENDED POSITION WITH AID OF NAVIGATION DURING A REVISION SURGERY 2 DAYS LATER. THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THE INCORRECT SCREW PLACEMENT. DESPITE CORRECT PLACEMENT OF THE REVISED SCREW, THE OUTCOME OF THE REVISION SURGERY WAS CONSIDERED NOT SUCCESSFUL FOR REASONS UNRELATED TO NAVIGATION AND ITS USE (DURING FINAL TIGHTENING OF THE REVISED L5 SCREW, THE L4 SCREW PULLED OUT - ACC. TO THE SURGEON THIS WAS FULLY DUE TO SOFT PATIENT BONE CONDITION, AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22466906 ↗
• InjuryJul 9, 2025Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE THORACIC AND LUMBAR SPINE, FOR A FUSION OF VERTEBRAE T3 TO L2 FOR KYPHOSIS CORRECTION, WITH INTENDED PLACEMENT OF 24 SPINE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 2.0. FROM AN INTRA-OPERATIVE CT SCAN, THE SURGEONS DETERMINED THAT THE SPINE SCREWS PLACED DEVIATED FROM THEIR INTENDED POSITIONS WITH A TENDENCY TO THE PATIENT'S RIGHT, WITH 3 SCREWS ON THE LEFT SIDE - IN LEFT T3, T9 AND T10 - DEVIATING SHIFTED BY CA. 3-4MM MEDIAL. THE SURGEONS DECIDED THAT THESE 3 SCREWS NEEDED RE-POSITIONING, REMOVED AND RE-PLACED THEM WITH NAVIGATION TO THEIR CORRECT POSITIONS AT THE VERY SAME SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE FINAL 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 PLACEMENTS. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 20-30MIN. THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS ALSO NOT PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22458469 ↗
• InjuryMay 23, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A MINIMALLY INVASIVE SURGERY ON THE THORACIC AND LUMBAR SPINE FOR A PERCUTANEOUS DORSAL STABILIZATION OF VERTEBRAE T12 TO L2, DUE TO A FRACTURE ON L1, WITH INTENDED PLACEMENT OF 4 VERTEBRA SCREWS BILATERAL FOR FIXATION, AND 2 VERTEBRA STENTS TO APPLY BONE FILLING, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 2.0. FROM AN INTRA-OPERATIVE CT SCAN, THE SURGEON DETERMINED THAT OF 1 OF THE 6 SPINE K-WIRES PLACED WITH THE AID OF NAVIGATION, IN VERTEBRA LEFT T12, DEVIATED SHIFTED MEDIAL BY CA. 5MM FROM ITS INTENDED POSITION. THE DEVIATING K-WIRE WAS REMOVED AND RE-PLACED TO ITS INTENDED POSITION WITH NAVIGATION AT THE VERY SAME SURGERY, BEFORE INSERTING ITS FOLLOWING SPINE SCREW. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL PLACEMENTS CORRECT AT THE END OF THE SURGERY. - THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT RESULTING, DESPITE THERE WAS A DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO A BONE BREACH TO THE SPINAL CORD BY THE DEVIATING PLACEMENT, AND THERE WAS ALSO NO NEGATIVE EFFECT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 15MIN. - THERE WERE FURTHER NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077138 ↗
• InjuryMay 21, 2025Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE LUMBAR SPINE AND SACROILIAC AREA, FOR A FUSION OF VERTEBRAE L4 TO S2 AND ALAR-ILIAC, WITH INTENDED PLACEMENT OF 8 SPINE SCREWS -INCLUDING 2 S2AI SCREWS- BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 2.0. FROM AN INTRA-OPERATIVE C-ARM SCAN, THE SURGEON DETERMINED THAT OF 1 OF 8 SCREWS PLACED, THE RIGHT SIDED S2AI SCREW, DEVIATED AT THE SI JOINT MEDIAL BY CA. 3-4MM FROM ITS INTENDED POSITION. THE DEVIATING S2AI SCREW WAS REMOVED AND ITS PLACEMENT CORRECTED WITH NAVIGATION AT THE VERY SAME SURGERY. APPARENTLY, THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL PLACEMENTS CORRECT AT THE END OF THE SURGERY. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT REPORTED, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 30-60MIN. THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT REPORTED AS DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS NOT REPORTED PROLONGED EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059114 ↗
• InjuryMay 14, 2025Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE CERVICAL AND THORACIC SPINE FOR A FUSION OF VERTEBRAE C7 TO T4, DUE TO A TUMOR IN BETWEEN AND FOR A FOLLOWING CAGE PLACEMENT, WITH INTENDED PLACEMENT OF 8 SPINE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 2.0. AFTER PLACING THE 8 SCREWS BILATERALLY IN VERTEBRAE C7, T1, T3 AND T4 WITH NAVIGATION, THE SURGEON DETERMINED FROM AN INTRA-OPERATIVE C-ARM FLUOROSCOPIC CONTROL SCAN, THAT 2 OF THE SPINE SCREWS - IN BOTH SIDES OF C7 - DEVIATED FROM THEIR INTENDED POSITIONS SHIFTED BY CA. 10MM. THE 2 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 FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED. - 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, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 30MIN. - THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT NECESSARY, DONE OR PLANNED. HOSPITALIZATION WAS ALSO NOT PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016800 ↗
• InjuryMay 9, 2025Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A MINIMALLY INVASIVE SURGERY (B)(6) 2025) ON THE THORACOLUMBAR SPINE FOR FUSION OF VERTEBRAE T11-L3, DUE TO FRACTURE AT L1, WITH INTENDED PLACEMENT OF 8 SPINE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 2.0.1. DURING THE PROCEDURE, THE SURGEON DETECTED THAT 3 SPINE SCREWS PLACED WITH THE AID OF NAVIGATION DEVIATED FROM THEIR INTENDED POSITION (BILATERAL T11 AND RIGHT T12, BY 4-5 MM LATERALLY). ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF 3 OF THE 3 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 8 SCREW PLACEMENTS CORRECT AT THE END OF THE SURGERY. THERE WAS NO ACTUAL HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENTS, DESPITE A DIRECT (OR INCREASED) RISK TO HARM THE SPINAL CORD & NERVES DUE TO THE DEVIATING PLACEMENTS. THERE WAS NO OTHER HARM OR NEGATIVE EFFECT TO THE PATIENT REPORTED, NEITHER DUE TO THE PROLONGED ANEST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992704 ↗
• InjuryMay 9, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  AN OPEN SURGERY (ON (B)(6) 2025) ON THE LUMBAR SPINE FOR A L4/L5 STABILIZATION AND BILATERAL DECOMPRESSION, DUE TO L4/L5 SPONDYLOLISTHESIS WITH A LEFT L4/L5 RECESS HERNIATION, WITH INTENDED PLACEMENT OF 4 PEDICLE SCREWS BILATERAL, WAS PERFORMED WITH THE AID OF THE NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 2.0.0. FROM AN INTRA-OPERATIVE CT SCAN, THE SURGEON DISCOVERED THAT ALL OF THE 4 PEDICLE SCREWS PLACED WITH THE AID OF NAVIGATION DEVIATED FROM THEIR INTENDED POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992563 ↗
• InjuryMay 5, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A MINIMALLY INVASIVE SURGERY ON THE LUMBAR SPINE FOR A FUSION OF VERTEBRAE L3 TO L5, WITH INTENDED PLACEMENT OF 6 VERTEBRA SCREWS BILATERAL, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SPINE & TRAUMA NAVIGATION 2.0. WHEN THE PATIENT EXPERIENCED ISSUES AT THE FOLLOWING DAY AFTER THE SURGERY, THE SURGEON DETERMINED FROM AN IMAGING SCAN, THAT ONE OF THE 6 SPINE SCREWS PLACED, IN VERTEBRA RIGHT L3, DEVIATED FROM ITS INTENDED POSITION SHIFTED BY CA. 6-7MM, AND WAS PLACED INTO THE SPINAL CANAL. A REVISION SURGERY TO SUCCESSFULLY CORRECT THIS SCREW PLACEMENT TOOK PLACE THE SAME DAY OF DETECTION, I.E. THE FOLLOWING DAY AFTER THE ORIGINAL SURGERY, WITH THE SAME NAVIGATION, ON (B)(6) 2025. ACCORDING TO THE SURGEON (TREATING CLINICIAN): DUE TO THE DEVIATING SPINE SCREW PLACED INTO THE SPINAL CANAL, THE PATIENT IS UNABLE TO MOVE THEIR LEGS AND EXPERIENCES LACK OF BOWEL CONTROL. THESE NEGATIVE EFFECTS FOR THE PATIENT REMAIN AT THE CURRENT POINT IN TIME. EXCEPT FOR THE REVISION SURGERY, THERE WERE NO FURTHER REMEDIAL SURGICAL ACTIONS PERFORMED FOR THIS PATIENT SINCE. THERE WAS NO PROLONGATION OF THE ORIGINAL SURGERY/ANESTHESIA DUE TO THE DEVIATING PLACEMENT, AND THERE WAS NO ADDITI

  Patient problems: Movement Disorder; Paraplegia

  MAUDE report 21958843 ↗
• InjuryMay 2, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  AN OPEN SURGERY ON THE LUMBAR SPINE FOR A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) OF VERTEBRAE L4 TO L5, DUE TO SPONDYLOLISTHESIS, WITH INTENDED PLACEMENT OF 4 SPINE SCREWS BILATERAL FOR FIXATION (AT L4 AND L5), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 2.0. FROM AN INTRA-OPERATIVE VERIFICATION SCAN, THE SURGEONS DISCOVERED THAT A K-WIRE, PLACED WITH THE AID OF NAVIGATION, DEVIATED FROM ITS INTENDED POSITION (AT RIGHT L4). ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF 1 OF THE 2 K-WIRES PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY, AND THE K-WIRE WAS CORRECTED TO ITS INTENDED POSITION 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 K-WIRE-PLACEMENT. - THERE WAS NEITHER HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING INITIAL K-WIRE PLACEMENT, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 15 MINUTES. - THERE WERE FURTHER NO REMEDIAL ACTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21948858 ↗
• InjuryApr 25, 2025Use of Device Problem; Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE LUMBOSACRAL SPINE FOR A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF), WITH INTENDED PLACEMENT OF 4 PEDICLE SCREWS BILATERAL FOR FIXATION (AT L5 AND S1), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 2.0. FROM INTRA-OPERATIVE ANTEROPOSTERIOR (AP) AND LATERAL X-RAY SCANS, THE SURGEON DISCOVERED THAT 3 OF THE 4 PEDICLE SCREWS PLACED WITH THE AID OF NAVIGATION DEVIATED FROM THEIR INTENDED POSITIONS (BY 7- 10 MM CRANIALLY AT RIGHT L5 AND BOTH SIDES OF S1). ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF 3 OF THE 4 PEDICLE 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 PLACEMENTS. THERE WAS NEITHER HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING INITIAL PLACEMENTS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909742 ↗
• InjuryApr 17, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A MINIMALLY INVASIVE SURGERY (ON (B)(6) 2025) ON THE LUMBOSACRAL SPINE FOR A POSTERIOR FUSION OF VERTEBRAE L5-S1, DUE TO SPONDYLOLISTHESIS, WITH INTENDED PLACEMENT OF 4 SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 2.0.1. (IN THE SAME SURGERY, PRIOR TO THE NAVIGATED PART, A L5-S1 ANTERIOR FUSION HAD BEEN PERFORMED WITHOUT AID OF NAVIGATION.) DURING THE PROCEDURE, THE SURGEON DISCOVERED THAT THE THIRD K-WIRE PLACED WITH THE AID OF NAVIGATION DEVIATED FROM ITS INTENDED POSITION (AT RIGHT L5, LATERAL BY CA. 3-5MM). ACCORDING TO THE SURGEON (TREATING CLINICIAN): -THE DEVIATION OF THE THIRD K-WIRE PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY, AND (AFTER ONE ATTEMPT TO REPLACE IT WITH AID OF NAVIGATION, WHICH LED TO THE SAME DEVIATION) THE K-WIRE WAS CORRECTED TO ITS INTENDED POSITION WITHOUT AID OF 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 OF HARM TO A CRITICAL STRUCTURE DUE TO THE DEVIATING K-WIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855850 ↗