Spine &Trauma Navigation 3.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 04056481144906), received between Jun 17, 2025 and Sep 28, 2026 — classified as 37 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (36 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 37 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Use of Device Problem

  An open surgery on the thoracic and lumbar spine for a fusion of vertebrae T3 to L3, for scoliosis correction, with the intended placement of 21 screws, was performed with the aid of the display by the Brainlab Navigation software Spine & Trauma Navigation 3.0. During the placement of a spine screw at L3 on the patient's left side, with the aid of navigation, the surgeon discovered that the screw deviated from its intended position. This deviation was confirmed using a feeler.According to the surgeon (treating clinician):The deviation of one screw placed in the spine with the aid of navigation was detected by the surgeon before finalizing the surgery, and the screw was corrected to its intended position with navigation at the very same surgery.Non-removal of the deviating screw would have led to a critical harm to the patient (damage to the intervertebral disc).The outcome of the surgery was successful as intended, with all screw placements correct at the end of the surgery.There was no harm/negative clinical effect to the patient, including due to the prolonged anesthesia of 2 minutes, and there were no further medical/surgical remedial actions necessary, done or planned.Hospitali

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913082 ↗
• InjurySep 23, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872620 ↗
• InjurySep 18, 2026Insufficient Device Problem Information

  An open surgery on the thoracic spine for a fusion of vertebrae T9 to T4, extending the existing spinal construct, due to adjacent segment degeneration, with intended placement of 8 vertebra screws bilateral for fixation, was performed with the aid of Brainlab Spine & Trauma Navigation 3.0.After placing the 8 spine screws, the surgeon detected from an intra-operative verification imaging scan, that all screws deviated from their intended positions by ca. 3-5mm - on the left side medially, on the right side laterally. The surgeon decided to remove the deviating screws and to re-place them to their correct positions with navigation at the very same surgery.According to the surgeon (treating clinician):- A dural tear with cerebrospinal fluid leakage occurred at vertebra left T6, requiring the application of bone wax to avoid/prevent a serious injury.- The outcome of the surgery was successful as intended, with all placements correct at the end of the surgery.- There was no resulting critical or remaining harm / negative clinical effect to the patient due to the deviating initial placements, also not due to the prolongation of the surgery/anesthesia of ca. 40min.- There were further no

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 50816992 ↗
• InjurySep 2, 2026Use of Device Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50560435 ↗
• InjuryAug 7, 2026Use of Device Problem

  A minimally invasive surgery on the lumbar spine for a fusion of vertebrae L3 to L5, due to spine instability with scoliosis, with intended placement vertebra screws bilateral for fixation, including cage implants in between L3/L4 and L4/L5, was performed with the aid of the Brain lab Spine & Trauma Navigation 3.0.After drilling the pilot holes bilateral in vertebra L5 and placing their following (temporary) k-wires with navigation, the surgeon determined from an intra-operative fluoroscopic verification, that both pilot holes and k-wires placed deviated shifted caudally by ca. 3-4mm from their intended positions. The surgeon decided to continue the surgery with conventional methods, and to leave the deviating k-wires in L5 in place to guide their following screw placements, where necessary choosing a shorter screw length.According to the surgeon (treating clinician):The outcome of the surgery was successful as intended.There was no direct (or increased) risk to harm a critical structure due to the deviating placements.There was no harm nor negative effect to the patient resulting, also not due to the surgery/anesthesia prolongation of ca. 20-30min.There were further no remedial ac

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50170813 ↗
• InjuryJul 30, 2026Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  An open surgery on the thoracic and lumbosacral spine, for a fusion of vertebrae T8 to S2, with intended placement of 24 screws bilateral for fixation, was performed with the aid of the display by the Brainlab Navigation software Spine & Trauma Navigation 3.0.From a post-operative CT scan the surgeon discovered that 2 of the 24 screws, placed with the aid of navigation, deviated from their intended positions (at T9 and the ilium, both on the patient's right side).According to the surgeon (treating clinician):- The deviation of 2 of the 24 screws placed with the aid of navigation was detected by the surgeon with a post-operative CT. A revision surgery was scheduled and took place five days after the initial surgery.- The outcome of the revision surgery was successful, with the deviating screw placements corrected to their intended positions.- There was no actual harm/negative clinical effect to the patient due to the deviating placements.- The duration of the original surgery/anesthesia was not prolonged due to this issue (the deviations were detected only afterwards). There was no negative clinical effect on the patient due to anesthesia duration of ca. 1.25 h for the revision surg

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50079721 ↗
• InjuryJul 27, 2026Use of Device Problem; Insufficient Device Problem Information

  An open surgery on the thoracic and lumbar spine for a fusion of vertebrae T7 to L2, was performed with the aid of the display by the Brainlab Navigation software Spine & Trauma Navigation 3.0.Initially, 6 spine screws were intended to be placed bilaterally at vertebrae T8, L1 and L2. From an intra-operative CT scan, the surgeon discovered that all 6 screws placed at T9, L1 and L2 with the aid of navigation deviated from their intended positions.While correcting the spine screw placements, it was determined that sufficient screw anchorage was not possible at vertebra T9 due to pathologically altered bone quality.This necessitated the extension of the instrumentation cranially with 4 additional spine screws placed bilaterally at T7 and T8.According to the 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 the screw positions were corrected with navigation at the very same surgery.The outcome of the surgery was successful as intended with all screws placed in their correct final positions.There was a screw malposition with penetration of the thoracic spinal cord. The extent of t

  Patient problems: Spinal Cord Injury

  MAUDE report 50005843 ↗
• InjuryApr 23, 2026Use of Device Problem

  AN OPEN SURGERY ON THE LUMBAR AND SACRAL SPINE FOR AN EXTENSION FUSION OF VERTEBRAE L5 AND S1, DUE TO SPONDYLOLISTHESIS AT THESE VERTEBRAE, WITH INTENDED PLACEMENT OF 2 SPINE SCREWS BILATERAL, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 3.0. AFTER PLACING THE FIRST SCREW IN VERTEBRA LEFT S1, THE SURGEON DETECTED THAT THE NAVIGATION ACCURACY HAD DECREASED, AND DETERMINED FROM INTRA-OPERATIVE C-ARM IMAGING, THAT THE LEFT S1 SCREW DEVIATED FROM ITS INTENDED POSITION SHIFTED SUPERIORLY AND INTO THE DISC SPACE. THE SURGEON DECIDED TO REMOVE THE DEVIATING SCREW AND TO RE-PLACE IT WITH NAVIGATION TO ITS CORRECT POSITION AT THE VERY SAME SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL SPINE SCREW PLACEMENTS CORRECT AT THE END OF THE SURGERY. THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THIS PLACEMENT'S DEVIATION. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT RESULTING DUE TO THE DEVIATING PLACEMENT, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF MAXIMUM CA. 30MIN. THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966058 ↗
• InjuryApr 21, 2026Use of Device Problem

  AN OPEN SURGERY ON THE LUMBARSACRAL SPINE FOR EXTENSION OF EXISTING FUSION OF L4 AND L5, WITH INTENDED PLACEMENT OF 6 PEDICLE SCREWS BILATERAL FOR FIXATION (AT L4, L5 AND S1), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 3.0. FROM AN INTRA-OPERATIVE C-ARM SCAN, THE SURGEON DISCOVERED THAT OF 1 OF THE 2 SCREWS PLACED WITH THE AID OF NAVIGATION DEVIATED FROM ITS INTENDED POSITION (AT S1, WITH THE AMOUNT OF THE DEVIATION FROM THE INTENDED POSITION OF 10 MM) ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF 1 OF THE 2 PEDICLE 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 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 NO HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING INITIAL PLACEMENTS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONG OF 1 HOUR. THERE WERE FURTHER NO REMEDIAL A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24935202 ↗
• InjuryApr 13, 2026Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE THORACIC SPINE FOR A STABILIZATION FUSION OF VERTEBRAE T4 TO T11, DUE TO A FRACTURE AT T5 AND T9, WITH INTENDED PLACEMENT OF 14 SPINE SCREWS BILATERAL, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SPINE & TRAUMA NAVIGATION 3.0. FROM AN INTRA-OPERATIVE CT SCAN, THE SURGEON DETECTED THAT THE SPINE SCREWS PLACED IN VERTEBRA RIGHT T4-T8 DEVIATED FROM THEIR INTENDED POSITION AND WERE BREACHING MEDIAL INTO THE SPINAL CANAL. THE SURGEON DECIDED TO REMOVE THE SCREW AND TO RE-PLACE IT TO ITS CORRECT POSITION WITH NAVIGATION AT THE VERY SAME SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): NON-REMOVAL / NON-REPLACEMENT OF THE DEVIATING SCREWS COULD HAVE POSSIBLY LED TO A CRITICAL HARM TO THE PATIENT, SINCE THEY HAD BREACHED INTO THE SPINAL CANAL 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, DESPITE A DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE AS THE SCREWS BREACHED INTO SPINAL CANAL. THERE WAS ALSO NO HARM /NEGATIVE CLINICAL EFFECT TO THE PATIENT DUE TO T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24857855 ↗
• InjuryApr 1, 2026Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE LUMBOSACRAL SPINE FOR A REVISION AND EXTENSION OF AN EXISTING POSTERIOR SPINAL FUSION FROM L5-S1 TO L4-S1, WITH INTENDED PLACEMENT OF 6 SPINE SCREWS BILATERAL FOR FIXATION (AT L4, L5 AND S1), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 3.0. FROM INTRA-OPERATIVE CT SCANS, THE SURGEON DISCOVERED THAT 5 OF THE 6 GUIDE WIRES PLACED IN THE SPINE WITH THE AID OF NAVIGATION DEVIATED FROM THEIR INTENDED POSITIONS (WITH A CA. 3 MM CRANIAL SHIFT). ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF FIVE OUT OF SIX GUIDE WIRES PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY, AND FOUR GUIDE WIRES WERE RE-PLACED TO THEIR INTENDED POSITIONS WITH NAVIGATION AT THE VERY SAME SURGERY. THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED. THERE WAS NO NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE DEVIATING PLACEMENTS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION CA. 1.5 HOURS. THERE WERE NO FURTHER REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755963 ↗
• InjuryMar 30, 2026Use of Device Problem; Improper or Incorrect Procedure or Method

  AN OPEN SURGERY ON THE LUMBAR SPINE FOR A FUSION OF VERTEBRAE L5 TO S1 DUE TO SPONDYLOLISTHESIS, WITH INTENDED PLACEMENT OF 4 SPINE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB (SPINE & TRAUMA NAVIGATION SPINE & TRAUMA 3.0.2). DURING THE PROCEDURE, AFTER PLACEMENT OF ALL FOUR SCREWS, INTRA OPERATIVE X RAYS SHOWED THAT THE LEFT S1 SCREW DEVIATED CRANIALLY FROM ITS INTENDED TRAJECTORY INTO THE DISC SPACE. THE SCREW WAS REMOVED AND REPLACED DURING THE SAME SURGERY USING NAVIGATION. ACCORDING TO THE LIMITED INFORMATION FROM THE HOSPITAL (AND THE INFORMATION RECEIVED FROM BRAINLAB REP. WHO WAS PRESENT DURING SURGERY): DEVIATING SCREW LEFT S1 WAS REVISED DURING THE SAME SURGERY WITH THE AID OF NAVIGATION, AND ALL SCREWS WERE ULTIMATELY CONFIRMED TO BE CORRECTLY PLACED AS INTENDED AT THE END OF THE SURGERY. THERE WAS NO REPORTED HARM NOR NEGATIVE EFFECT TO THE PATIENT RESULTING, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 15MIN. NO REMEDIAL ACTIONS FOR THE PATIENT WERE REPORTED AS PERFORMED, REQUIRED, OR PLANNED. A PROLONGATION OF HOSPITALIZATION WAS LIKEWISE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714371 ↗
• InjuryMar 25, 2026Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE THORACIC AND LUMBAR SPINE FOR A STABILIZATION FUSION OF VERTEBRAE T11 TO L1, DUE TO A FRACTURE OF T12, WITH INTENDED PLACEMENT OF 4 SPINE SCREWS BILATERAL, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SPINE & TRAUMA NAVIGATION 3.0. FROM AN INTRA-OPERATIVE CT SCAN, THE SURGEON DETECTED THAT THE SPINE SCREW PLACED IN VERTEBRA RIGHT T11 DEVIATED FROM ITS INTENDED POSITION, ANGULATED BY CA. 3-4MM MEDIAL AT ITS TARGET, AND BREACHING T11 MEDIAL INTO THE SPINAL CANAL. THE SURGEON DECIDED TO REMOVE THE SCREW AND TO RE-PLACE IT TO ITS CORRECT POSITION WITH NAVIGATION AT THE VERY SAME SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): NON-REMOVAL / NON-REPLACEMENT OF THE DEVIATING SCREW PLACED INTO THE SPINAL CANAL WOULD HAVE EXPECTEDLY LED TO A CRITICAL HARM TO THE PATIENT, SINCE IT HAD BREACHED AGAINST THE SPINAL CORD. 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 SURGERY/ANESTHESIA OF CA. 30-45MIN. THERE WERE FURTHER NO REMEDIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689437 ↗
• InjuryMar 3, 2026Use of Device Problem

  AN OPEN SURGERY ON THE LUMBAR AND SACRAL SPINE, FOR A FUSION OF VERTEBRAE L2 TO S1, INCLUDING REVISION OF A PRE-EXISTING FUSION OF L3-S1, WITH INTENDED PLACEMENT OF 10 SPINE SCREWS BILATERAL FOR FIXATION (INCLUDING RE-PLACEMENT OF 7 SCREWS TO THE SAME LOCATION AS BEFORE), WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 3.0. AFTER PLACING THE 10 SPINE SCREWS, THE SURGEON DETERMINED FROM AN INTRA-OPERATIVE C-ARM SCAN, THAT THREE SPINE SCREWS PLACED - IN VERTEBRAE LEFT L3 AND BILATERAL L2 - DEVIATED FROM THEIR INTENDED POSITIONS, RESULTING IN AN EXTRA-PEDICULAR TRAJECTORY. THE SURGEON DECIDED TO REMOVE AND RE-PLACE THE DEVIATING SCREWS TO THEIR CORRECT POSITIONS WITH NAVIGATION 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 PLACEMENT. - THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT RESULTING, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 30MIN. - THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494153 ↗
• InjuryFeb 19, 2026Use of Device Problem

  AN OPEN SURGERY ON THE SACRO-LUMBAR SPINE FOR A FUSION EXTENSION OF VERTEBRAE L2 TO L3 AND S1 TO S2 (PREVIOUS FUSION AT L4-L5), WITH LAMINECTOMY/DECOMPRESSION AND INTENDED PLACEMENT OF 8 SPINE SCREWS BILATERAL FOR FIXATION (AT L2, L3, S1, AND S2), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 3.0. FROM AN INTRA-OPERATIVE X-RAY SCAN, THE SURGEON DISCOVERED THAT TWO OF THE EIGHT SCREWS (AT RIGHT L2 & LEFT L3) PLACED WITH THE AID OF NAVIGATION DEVIATED FROM THEIR INTENDED POSITIONS INTO THE CANAL. ACCORDING TO THE LIMITED INFORMATION FROM THE HOSPITAL/SURGEON (DURING SURGERY): THE DEVIATION OF THE SCREWS PLACED IN THE PATIENT'S SPINE WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY, AND THE SCREWS WERE CORRECTED TO THEIR INTENDED POSITIONS AT THE VERY SAME SURGERY. THERE WAS NO HARM NOR NEGATIVE CLINICAL EFFECT TO THE PATIENT WAS REPORTED NEITHER DUE TO THE DEVIATING PLACEMENTS, NOR DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 60 MINUTES. NO FURTHER 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 24389817 ↗
• InjuryFeb 19, 2026Use of Device Problem

  AN OPEN SURGERY ON THE LUMBAR SPINE, FOR AN ANTERIOR AND POSTERIOR FUSION OF VERTEBRAE L3 TO L5, WITH INTENDED PLACEMENT OF 6 SPINE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 3.0. AFTER PLACING THE INTENDED SPINE SCREWS, THE SURGEON DETERMINED FROM INTRA-OPERATIVE VERIFICATION FLUOROSCOPIC IMAGING, THAT THE LAST 2 OF THE 6 SPINE SCREWS PLACED - IN VERTEBRAE RIGHT L4 AND L5 - DEVIATED FROM THEIR INTENDED POSITIONS, SHIFTED AND ANGULATED BY CA. 4-6MM, WITH THEIR TARGET POINTS ENTERING THE INTERVERTEBRAL DISC SPACE. THE SURGEON DECIDED TO REMOVE AND RE-PLACE THE 2 DEVIATING SCREWS TO THEIR CORRECT POSITIONS WITH NAVIGATION 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 INITIAL PLACEMENTS DEVIATING FROM THEIR DESIRED POSITIONS. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT RESULTING, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 2HRS. THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24386759 ↗
• InjuryFeb 12, 2026Use of Device Problem

  AN OPEN SURGERY ON THE THORACIC SPINE FOR A POSTERIOR FUSION OF VERTEBRAE T7 TO T10, WITH TUMOR RESECTION AND INTENDED PLACEMENT OF 8 SPINE SCREWS BILATERAL FOR FIXATION (AT T7, T8, T9, AND T10), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 3.0. FROM AN INTRA-OPERATIVE C-ARM SCAN, THE SURGEON DISCOVERED THAT FOUR OF THE EIGHT SCREWS (AT RIGHT T7 & LEFT T7-T9) PLACED WITH THE AID OF NAVIGATION DEVIATED FROM THEIR INTENDED POSITIONS: LATERAL DEVIATION ON THE RIGHT SIDE AND MEDIAL DEVIATION ON THE LEFT SIDE. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF THE SCREWS PLACED IN THE PATIENT'S SPINE WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY, AND THE SCREWS WERE CORRECTED TO THEIR INTENDED POSITIONS 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 NO NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE DEVIATING PLACEMENTS, ALSO NOT DUE TO SURGERY/ANESTHESIA PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321597 ↗
• InjuryFeb 6, 2026Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE LUMBAR SPINE FOR A PRONE TRANSPSOAS (PTP) FUSION OF VERTEBRAE L2 TO L5 - INCLUDING PLACEMENTS OF PTP CAGES AND EXTENDING A PRE-EXISTENT FUSION L3/L4, DUE TO ADJACENT SEGMENT DEGENERATION L2/L3 AND L4/L5 - WITH INTENDED PLACEMENT OF 8 SPINE SCREWS BILATERAL, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 3.0. AFTER PLACING THE 8 SPINE SCREWS WITH NAVIGATED INSTRUMENTS, THE SURGEON DETERMINED FROM INTRA-OPERATIVE C-ARM IMAGING, THAT 1 OF THE SCREWS - AT VERTEBRA LEFT L2 - DEVIATED FROM ITS INTENDED POSITION SHIFTED BY CA. 3MM MEDIALLY AND SUPERIORLY. THE SURGEON DECIDED TO REMOVE THIS ONE DEVIATING SCREW AND TO RE-PLACE IT WITH THE SAME NAVIGATED METHOD AS BEFORE - RESULTING IN A DEVIATION FROM ITS INTENDED POSITION SHIFTED BY AGAIN CA. 3MM, THIS TIME LATERALLY AND INFERIORLY, AS DETERMINED FROM ANOTHER INTRA-OPERATIVE VERIFICATION C-ARM SCAN. THE SURGEON REMOVED THIS SCREW AGAIN AND RE-PLACED IT WITH NAVIGATION TO ITS CORRECT POSITION AT THE VERY SAME SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL SPINE SCREW PLACEMENTS CORRECT AT THE END OF THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280095 ↗
• InjuryJan 21, 2026Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE SACRO-LUMBAR SPINE, FOR A POSTERIOR FUSION OF VERTEBRAE L2 TO S1, INCLUDING DECOMPRESSION OF L4 TUMOR, WITH INTENDED PLACEMENT OF 9 SPINE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 3.0 AFTER PLACING THE INTENDED SPINE SCREWS, THE SURGEON DETERMINED FROM AN INTRA-OPERATIVE O-ARM SCAN, THAT 3 OF THE 9 SPINE SCREWS PLACED DEVIATED FROM THEIR INTENDED POSITIONS, THE SURGEON DECIDED TO REMOVE AND RE-PLACE THE 3 DEVIATING SCREWS (AT LEFT L3, LEFT L5, AND RIGHT S1) TO THEIR CORRECT POSITION WITH NAVIGATION AT THE VERY SAME SURGERY. 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 AN INTRA-OPERATIVE O-ARM SCAN, AND THE PLACEMENT WERE CORRECTED TO THEIR INTENDED POSITION WITH NAVIGATION AT THE VERY SAME SURGERY. - THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL PLACEMENTS CORRECT/ACCEPTED AT THE END OF THE SURGERY. - THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THE INITIAL PLACEMENTS DEVIATING FROM THEIR DESIRED POSITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24134411 ↗
• InjuryJan 14, 2026Use of Device Problem

  AN OPEN SURGERY ON THE LUMBAR SPINE, FOR A POSTERIOR FUSION OF VERTEBRAE L3 TO L5, INCLUDING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) CAGE PLACEMENTS IN BETWEEN L3/L4 AND L4/L5, WITH INTENDED PLACEMENT OF 6 SPINE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 3.0. AFTER PLACING THE INTENDED SPINE SCREWS, THE SURGEON DETERMINED FROM AN INTRA-OPERATIVE O-ARM SCAN, THAT 2 OF THE 6 SPINE SCREWS PLACED - BOTH IN VERTEBRA L5 - DEVIATED FROM THEIR INTENDED POSITIONS, ANGULATED BY CA. 4MM AT THEIR TARGET POINTS. THE SURGEON DECIDED TO REMOVE AND RE-PLACE ONE OF THE DEVIATING SCREWS, IN RIGHT L5, TO ITS CORRECT POSITION WITH NAVIGATION AT THE VERY SAME SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL PLACEMENTS CORRECT/ACCEPTED AT THE END OF THE SURGERY. THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THE INITIAL PLACEMENTS DEVIATING FROM THEIR DESIRED POSITIONS. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT RESULTING, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 15-20MIN. THERE WERE FURTHER NO REMEDIAL ACTIONS F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065616 ↗
• InjuryDec 19, 2025Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE THORACIC SPINE, FOR A FUSION OF VERTEBRAE T2 TO T10, DUE TO DEGENERATIVE DISC DISEASE AND SPINE INSTABILITY, WITH INTENDED PLACEMENT OF 18 SPINE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 3.0. AFTER PLACING 12 OF THE INTENDED SPINE SCREWS, IN VERTEBRAE T2 TO T7, THE SURGEON DETERMINED FROM AN INTRA-OPERATIVE C-ARM SCAN, THAT THESE 12 SPINE SCREWS PLACED DEVIATED FROM THEIR INTENDED POSITIONS SHIFTED BY CA. 2-3MM CRANIALLY. THE SURGEON DECIDED TO REMOVE AND RE-PLACE THE 12 SCREWS TO THEIR CORRECT POSITIONS, AS WELL AS TO PLACE THE REMAINING 6 INTENDED SPINE SCREWS, UNDER FLUOROSCOPIC GUIDANCE 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 INITIAL PLACEMENTS DEVIATING FROM THEIR DESIRED POSITIONS. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT RESULTING, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 45MIN. THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847908 ↗
• InjuryDec 10, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  AN OPEN SURGERY ON THE THORACIC SPINE FOR A FUSION FROM T3 TO T8, DUE TO A FRACTURE IN T5, WITH INTENDED PLACEMENT OF 11 SPINE SCREWS, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 3.0. AFTER NAVIGATION ACCURACY WAS SUSPECTED TO NO LONGER BE ACCURATE, THE SURGEON DETERMINED WITH AN INTRA-OPERATIVE VERIFICATION CT SCAN, THAT THE 5 SPINE SCREWS PLACED WITH THE AID OF NAVIGATION TO THIS POINT, DEVIATED FROM THEIR INTENDED POSITIONS SHIFTED BY CA. 3-4 MM. DESPITE THIS WAS DETECTED BEFORE CONTINUING AND FINALIZING THE REMAINING PART OF THE SURGERY UNDER FLUOROSCOPIC GUIDANCE, THE SURGEON ACCEPTED THE POSITIONS OF THE SPINE SCREWS PLACED WITH NAVIGATION AND DECIDED NO REVISION TO BE NECESSARY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE OUTCOME OF THE SURGERY WAS CONSIDERED SUCCESSFUL, EVEN THOUGH THE NAVIGATED SCREW PLACEMENTS WERE NOT IN OPTIMAL POSITIONS. DESPITE THERE WAS INCREASED RISK OF HARM TO THE PATIENT DUE TO THE DEVIATING SCREW PLACEMENTS AND A SUPERIOR VERTEBRA PLATE WAS BROKEN, THERE WAS NO SERIOUS HARM FOR THE PATIENT. THERE WAS NO FURTHER NEGATIVE EFFECT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 20-30MIN FOR E.G. THE ADDITIONAL SCANS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768464 ↗
• InjuryDec 3, 2025Use of Device Problem; Use of Device Problem

  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 problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707508 ↗
• InjuryNov 7, 2025Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE LUMBAR SPINE FOR A FUSION OF VERTEBRAE L3 AND L4, DUE TO SPONDYLOLISTHESIS, WITH INTENDED PLACEMENT OF 4 SPINE SCREWS BILATERAL, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 3.0. AFTER PLACING THE 4 SPINE SCREWS, THE SURGEONS DETERMINED FROM INTRA-OPERATIVE VERIFICATION FLUORO IMAGING THAT 2 OF THE SCREWS - IN VERTEBRAE LEFT L3 AND RIGHT L4 - DEVIATED FROM THEIR INTENDED POSITIONS SHIFTED MAINLY CRANIALLY BY SEVERAL MM AND WERE NOT IN THE PEDICLE AS DESIRED. THE 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 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 TO HARM A CRITICAL ANATOMICAL STRUCTURE DUE TO THE DEVIATING PLACEMENTS. - THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING INITIAL PLACEMENTS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 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 23495282 ↗
• InjuryNov 5, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  AN OPEN SURGERY ON THE LUMBOSACRAL SPINE FOR A FUSION OF VERTEBRAE L4 TO S1, DUE TO INSTABILITY, WITH INTENDED PLACEMENT OF 6 SPINE SCREWS BILATERAL FOR FIXATION (AT L4, L5 AND S1), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 3.0. AFTER CREATING A PILOT HOLE AT VERTEBRA L4 ON THE PATIENT'S RIGHT, THE SURGEON DETECTED A LATERAL BREACH OF THE PEDICLE. THE PILOT HOLE HAD BEEN CREATED, WITH THE AID OF NAVIGATION, AT A DIFFERENT LOCATION IN THE SPINE THAN INTENDED. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF 1 PILOT HOLE CREATED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY, AND IT WAS CORRECTED TO ITS INTENDED POSITION WITH NAVIGATION AT THE VERY SAME SURGERY. - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL SCREW PLACEMENTS IN THEIR CORRECT POSITIONS AT THE END OF THE SURGERY. - DESPITE A DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO THE DEVIATING PILOT HOLE, THERE WAS NEITHER HARM NOR NEGATIVE CLINICAL EFFECT TO THE PATIENT, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 30 MINUTES. - THERE WERE NO FURTHER REMEDIAL AC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477837 ↗