Navigation Software Spine & Trauma 3DRecalls & reported problems across all models

We found 2 models of Navigation Software Spine & Trauma 3D by Brainlab SE in the FDA's device registry (GUDID). Together they are named in 108 adverse event reports in the FDA's MAUDE database, received between Sep 30, 2016 and Jan 30, 2025 — classified as 87 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (105 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Navigation Software Spine & Trauma 3D problems

Navigation Software Spine & Trauma 3D models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Navigation Software Spine & Trauma 3D 2.6

  Neurological Stereotaxic Instrument
  103 reports
• Navigation Software Spine & Trauma 3D 2.5

  Neurological Stereotaxic Instrument
  5 reports

Recent Navigation Software Spine & Trauma 3D adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJan 30, 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 FUSION OF L4-L5 WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA 3D 2.6. FROM AN INTRA-OPERATIVE FLUOROSCOPY IMAGE, THE SURGEON DETECTED THAT ONE PLACEMENT PERFORMED WITH THE AID OF NAVIGATION DEVIATED FROM ITS INTENDED POSITION AND WAS CORRECTED TO ITS FINAL INTENDED POSITION WITHOUT THE AID OF NAVIGATION. FURTHER DETAILS OF THE PROCEDURE AND THE EFFECTS ON THE PATIENT COULD NOT YET BE RETRIEVED FROM THE HOSPITAL, BRAINLAB CONTINUES TO FOLLOW UP WITH THE USER FACILITY.

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

  MAUDE report 21272548 ↗
• InjuryJul 26, 2024Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE THORACIC SPINE FOR A FUSION OF VERTEBRAE T7-T10, DUE TO A FRACTURE AT T10/T11, WAS INTENDED TO BE PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE&TRAUMA 3D 2.6. DURING THE PROCEDURE THE SURGEON: - WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF VERTEBRA T7. - ACQUIRED AN INTRA-OPERATIVE 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 THE NAVIGATED POINTER TO DETERMINE THE LOCATION OF THE PILOT HOLES, AND OPENED THE CORTICAL BONE WITH A NOT NAVIGATED NON-BRAINLAB DRILL AT THE DETERMINED LOCATIONS. - USED A NON-BRAINLAB THORACIC PROBE, CALIBRATED TO THE NAVIGATION FOR INSTRUMENT POSITION DISPLAY ON THE PATIENT SCAN, TO EXPAND/FINALIZE THE PILOT HOLES IN THE VERTEBRAE FOR THE FOLLOWING SCREWS. - PLACED THE SPINE SCREWS AT T7-T10 FOLLOWING THE PILOT HOLES WITH A NON-BRAINLAB NOT NAVIGATED SCREWDRIVER. - ACQUIRED AN INTRA-OPERATIVE C-ARM SCAN TO VERIFY THE SCREW PLACEMENTS AND DETERMINED THAT ALL 8 SCREWS PLACED WITH THE AID OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19836821 ↗
• InjuryApr 15, 2024Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  AN OPEN SURGERY ON THE THORACIC AND LUMBAR SPINE FOR A FUSION OF VERTEBRAE T7 TO L1, DUE TO A FRACTURE AT THE T10,T11 DISC SPACE FROM A CAR ACCIDENT, WAS INTENDED TO BE PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA 3D 2.6. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF VERTEBRA T10. USED THE NAVIGATED SPINE POINTER FOR SURFACE MATCHING TO ACQUIRE REGISTRATION POINTS ON THE BONE OF VERTEBRA T10 TO REGISTER THE CURRENT PATIENT ANATOMY TO THE NAVIGATION, MATCHING IT TO A FORMERLY ACQUIRED PATIENT CT SCAN IMPORTED INTO THE NAVIGATION. VERIFIED THE REGISTRATION AND ACCEPTED THE NAVIGATION ACCURACY TO PROCEED. STARTING WITH VERTEBRA RIGHT T8, USED THE NAVIGATED POINTER TO DETERMINE THE LOCATION OF THE PILOT HOLE FOR THE INTENDED SCREW PLACEMENT. USED A NOT NAVIGATED NON-BRAINLAB DRILL TO OPEN THE CORTICAL BONE AT THE DETERMINED LOCATION, AND CHECKED THE OPENING WITH THE NAVIGATED POINTER. ALIGNED THE NAVIGATED DRILL GUIDE WITH INSTRUMENT POSITION DISPLAY ON THE PATIENT SCAN, AND CREATED THE FULL PILOT HOLE DRILLING THROUGH THE DRILL GUIDE. DETECTED CEREBROSP

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 19105185 ↗
• InjuryDec 15, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  AN OPEN SURGERY ON THE SPINE FOR A LUMBO-SACRAL FUSION OF VERTEBRAE L2 TO S1, WITH INTENDED PLACEMENT OF 10 VERTEBRA SCREWS BILATERAL, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE&TRAUMA 3D 2.6. A PRE-OPERATIVE CT SCAN ACQUIRED ON THE DAY OF THE SURGERY, WITH THE PATIENT IN A SUPINE POSITION, WAS USED TO NAVIGATE ON. DURING THE PROCEDURE, THE SURGEONS: - WITH THE PATIENT IN PRONE POSITION ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF VERTEBRA S1. - PERFORMED THE INITIAL SURFACE MATCHING REGISTRATION BY ACQUIRING REGISTRATION POINTS WITH THE NAVIGATED POINTER ON THE BONE SURFACE OF VERTEBRA L4, ADDITIONALLY ACQUIRED REGISTRATION POINTS FROM MULTIPLE FURTHER VERTEBRA LEVELS OF THE SPINE, TO MATCH THE PRE-OPERATIVE CT SCAN DISPLAYED BY THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. - VERIFIED THE REGISTRATION AND ACCEPTED THE ACCURACY TO PROCEED. - USED THE NAVIGATED DRILL GUIDE 3.2MM WITH INSTRUMENT POSITION DISPLAY ON THE PATIENT SCAN TO DRILL THE PILOT HOLES, THE PATHS FOR THE SCREWS IN THE VERTEBRA, THROUGH IT. - PLACED THE SPINE SCREWS WITH A NON-NAVIGATED NON-BRAINLAB SCREWDRIVER INTO THE PILOT HOLES, FOLLOWING THEIR PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334010 ↗
• InjurySep 19, 2023Use of Device Problem; Use of Device Problem

  AN MINIMALLY INVASIVE SURGERY ON THE LUMBAR SPINE FOR A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) OF VERTEBRAE L4-L5, WITH INTENDED PLACEMENT OF 4 VERTEBRA SCREWS BILATERAL FOR FIXATION (AT L4-L5), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA 3D 2.6. DURING THE PROCEDURE THE SURGEON: - WITH THE PATIENT IN PRONE POSITION ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE ILIAC CREST. - ACQUIRED AN INTRA-OPERATIVE 3D (X-RAY) 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. - PLANNED THE INCISIONS USING A NAVIGATED POINTER. - PREPARED THE PEDICLE WITH A MALLET TO CREATE A PILOT HOLE WITH THE NAVIGATED PEDICLE ACCESS NEEDLE. - INSERTED A K-WIRE, AND PROCEEDED WITH THE SAME APPROACH UNTIL ALL 4 K-WIRES IN L4 AND L5 WERE PLACED. - PERFORMED A DECOMPRESSION AND PLACED TLIF CAGE. - USED A NAVIGATED SCREWDRIVER TO PLACE SCREWS INTO L4 AND L5 VERTEBRAL BODIES AND WITH THAT DETERMINED A MINOR NAVIGATION INACCURACY, BUT NEVERTHELESS CONTINUED THE USE OF NAVIGATION AS AN AID. FURTHER WHEN WHEN PLACING THE SCREW A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773093 ↗
• InjuryJul 13, 2023Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE LUMBAR SPINE FOR A FUSION OF VERTEBRAE L4 TO L5, WITH INTENDED PLACEMENT OF 4 VERTEBRA SCREWS BILATERAL FOR FIXATION (AT L4 AND L5), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE&TRAUMA 3D 2.6.DURING THE PROCEDURE THE SURGEON:- WITH THE PATIENT IN PRONE POSITION ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SACRUM.- ACQUIRED AN INTRA-OPERATIVE 3D (X-RAY) 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 THE BRAINLAB POINTER TO DETERMINE THE CORRECT ENTRY POINT AND ANGLE OF THE SCREW ON L5- USED THE BRAINLAB DRILL GUIDE TO MAKE A HOLE WITH THE INTENDED ANGULATION, AND A NAVIGATED NON-BRAINLAB TAP TO MAKE THE HOLE BIGGER- PLACED THE SCREW WITH A NAVIGATED NON-BRAINLAB SCREWDRIVER INTO THE PREPARED PATH IN L5.- ACQUIRED AN X-RAY IMAGE TO CHECK THE SCREW PLACEMENT, DETERMINED THAT THE SCREW WAS PLACED AT THE RIGHT ENTRY POINT, BUT ANGLED TOO FAR LATERALLY THAN INTENDED.- RECHECKED THE INSTRUMENTS AND DETERMINED AN INACCURACY OF THE NON-BRAINLAB TAP AND SCREWDRIVER- DECIDED TO REMOVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316445 ↗
• InjuryMay 15, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  AN OPEN SURGERY (ON (B)(6) 2023) ON THE SPINE FOR FUSION OF L4-5 AND DECOMPRESSION OF L4-L5-S1, DUE TO LUMBAR RADICULOPATHY AND SPONDYLOLISTHESIS AT L4-5, WITH INTENDED PLACEMENT OF 4 SCREWS, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SOFTWARE SPINE & TRAUMA 3D NAVIGATION 2.5. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF VERTEBRA L4. USED THE NAVIGATED POINTER FOR SURFACE MATCHING TO ACQUIRE REGISTRATION POINTS ON THE BONE OF VERTEBRA L4 TO REGISTER THE CURRENT PATIENT ANATOMY TO THE NAVIGATION, MATCHING IT TO A PRE-OPERATIVELY ACQUIRED CT SCAN. VERIFIED THE REGISTRATION AND ACCEPTED THE ACCURACY TO PROCEED. PLANNED SCREW TRAJECTORIES FOR RIGHT AND LEFT L4 USING THE NAVIGATED DRILL GUIDE . PLACED A K-WIRED AT RIGHT L4 USING THE NAVIGATED DRILL GUIDE AND NAVIGATED NON-BRAINLAB TAP. VERIFIED THE REGISTRATION ACCURACY AND PROCEEDED. PLACED A SCREW AT LEFT L4 USING THE NAVIGATED DRILL GUIDE, A NAVIGATED NON-BRAINLAB TAP, AND A NON-NAVIGATED NON-BRAINLAB SCREWDRIVER. USED THE NAVIGATED POINTER PERIODICALLY TO VERIFY REGISTRATION ACCURACY. ACQUIRED AN X-RAY AND DETERMINED THAT K-WIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929252 ↗
• InjuryFeb 21, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A MINIMALLY INVASIVE SURGERY ON THE LUMBAR SPINE FOR FUSION AT VERTEBRAE L2-L5, WITH INTENDED PLACEMENT OF 8 BILATERAL PEDICLE SCREWS FOR FIXATION, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA 3D 2.6. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE (LEFT) ILIAC CREST USING THE 2-PIN FIXATOR WITH SCHANZ PINS. ACQUIRED AN INTRAOPERATIVE CT SCAN WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION, AND VERIFIED AND ACCEPTED THE ACCURACY OF THE REGISTRATION TO PROCEED. CALIBRATED THE BRAINLAB PEDICLE ACCESS NEEDLE (PAN) AND A NON-BRAINLAB SCREWDRIVER TO THE NAVIGATION, AND VERIFIED AND ACCEPTED THE ACCURACY OF THE CALIBRATIONS TO PROCEED. USED THE NAVIGATED POINTER TO DETERMINE INCISION LOCATION OVER L2-L5. USED THE NAVIGATED PAN TO OPEN THE PEDICLE AT LEFT L2, PLACED A K-WIRE THROUGH THE INSTRUMENT INTO THE PEDICLE, REMOVED THE PAN LEAVING THE K-WIRE IN PLACE, USED THE NAVIGATED SCREWDRIVER TO PLACE A SCREW OVER THE K-WIRE, AND REMOVED THE K-WIRE AFTERWARDS. REPEATED THIS SURGICAL WORKFLOW TO PLACE SCREWS IN THE LEFT PEDICLES OF L3-L5. WHIL

  Patient problems: Muscle Weakness/Atrophy; Numbness

  MAUDE report 16412208 ↗
• InjuryFeb 15, 2023Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE THORACIC SPINE FOR A FUSION OF VERTEBRAE T1 TO T7, DUE TO SPONDYLOLISTHESIS CAUSED BY A TUMOR, WITH INTENDED PLACEMENT OF 9 SPINE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE&TRAUMA 3D 2.6. FROM FORMER SURGERIES, THE PATIENT ALREADY HAD PARTS OF SPINAL BONE MISSING AT THE VERTEBRAE T2 TO T6. DURING THE PROCEDURE THE SURGEONS: WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF VERTEBRA T7. ACQUIRED AN INTRA-OPERATIVE CT 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 NAVIGATION ACCURACY TO PROCEED. STARTING AT THE LOWER VERTEBRAE, FIRST AT LEFT T6, USED A NON-BRAINLAB PEDICLE ACCESS NEEDLE (PAN) BEFOREHAND MANUALLY CALIBRATED TO NAVIGATION FOR INSTRUMENT POSITION DISPLAY, TO DETERMINE THE SCREW TRAJECTORY AND TO PLAN THE SCREW PLACEMENTS. CREATED THE PILOT HOLES FOR THE SPINE SCREWS IN THE VERTEBRAE WITH THE PAN. INSERTED K-WIRES THROUGH THE NAVIGATED TUBE OF THE PAN INTO THE PREPARED PILOT HOLES. THREADED THE PILOT HOLES W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16379145 ↗
• InjuryFeb 13, 2023Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE LUMBAR SPINE FOR A FUSION OF VERTEBRAE L4 AND L5 WITH WINDOWING, DUE TO SPONDYLOLISTHESIS, 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 3D 2.6. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF VERTEBRA L3. ACQUIRED AN INTRA-OPERATIVE CT 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 NAVIGATION ACCURACY TO PROCEED. STARTING WITH RIGHT L4, USED A NON-BRAINLAB PEDICLE ACCESS NEEDLE (PAN) BEFOREHAND MANUALLY CALIBRATED TO NAVIGATION FOR INSTRUMENT POSITION DISPLAY, TO DETERMINE THE SCREW TRAJECTORY AND TO PLAN THE SCREW PLACEMENTS. CREATED THE PILOT HOLES FOR THE SPINE SCREWS IN THE VERTEBRAE WITH THE NAVIGATED PAN. INSERTED K-WIRES THROUGH THE NAVIGATED TUBE OF THE PAN INTO THE PREPARED PILOT HOLES. THREADED THE PILOT HOLES WITH A NOT NAVIGATED NON-BRAINLAB CANNULATED TAP FOLLOWING THE K-WIRES, AND PLACED THE CANNULATED SPINE SCREWS WITH AN ALSO NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363572 ↗
• InjuryNov 17, 2022Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE LUMBAR AND SACRAL SPINE FOR A LUMBAR FUSION OF VERTEBRAE L3 TO S1 AND DECOMPRESSION, WITH INTENDED PLACEMENT OF 8 VERTEBRA SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE&TRAUMA 3D 2.6. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF VERTEBRA L3. ACQUIRED AN INTRA-OPERATIVE 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. STARTING WITH LEFT S1, USED THE NAVIGATED POINTER TO DETERMINE THE TRAJECTORY FOR THE SCREWS, AND THE NAVIGATED DRILL GUIDE 2.6MM TO DRILL INTO THE VERTEBRAE TO CREATE THE PILOT HOLES BILATERAL. CALIBRATED A NON-BRAINLAB TAP TO THE NAVIGATION FOR INSTRUMENT POSITION DISPLAY TO THREAD THE PILOT HOLES. PLACED THE SCREWS WITH A NON-BRAINLAB SCREWDRIVER, ALSO BEFOREHAND CALIBRATED TO NAVIGATION, INTO AND FOLLOWING THE THREADED PILOT HOLES. ACQUIRED VERIFICATION INTRA-OPERATIVE C-ARM FLUORO (X-RAY) SHOTS, AND DETERMINED THAT THE LAST SCREW PLACED, IN

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 15813885 ↗
• InjuryJun 13, 2022Use of Device Problem; Use of Device Problem

  A SURGERY ON THE LUMBAR SPINE FOR LOW GRADE SPONDYLOLISTHESIS AT L3-L5, INCLUDING AN XLIF (EXTREME LATERAL INTERBODY FUSION) FOLLOWED BY MINIMALLY INVASIVE (MIS) POSTERIOR SPINAL FUSION FROM L3-L5 WITH INTENDED PLACEMENT OF 6 PEDICLE SCREWS FOR FIXATION, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SPINE & TRAUMA 3D NAVIGATION SOFTWARE 2.6. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT PRONE AND ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF T12. ACQUIRED AN INTRAOPERATIVE CT SCAN WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION, VERIFIED THE ACCURACY OF THE REGISTRATION AND ACCEPTED THE REGISTRATION TO PROCEED. CALIBRATED NON-BRAINLAB INSTRUMENTS (HAND DRILL/BURR, TAP, AND SCREWDRIVER) TO THE NAVIGATION, AND VERIFIED AND ACCEPTED THE ACCURACY OF THE CALIBRATED INSTRUMENTS TO PROCEED. CREATED PATHS IN THE PEDICLES AND PLACED SCREWS DOWN THE PREPARED PATHS USING THE NAVIGATED NON-BRAINLAB INSTRUMENTS FROM LEFT L5 TO LEFT L3, FOLLOWED BY RIGHT L5 TO RIGHT L3. OBTAINED A VERIFICATION INTRAOPERATIVE CT SCAN (WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION) AND DETECTED THAT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675170 ↗
• InjuryMay 4, 2022Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE LUMBOSACRAL SPINE FOR A POSTERIOR LUMBAR FUSION OF VERTEBRAE L3 TO S1 AND WITH SI, DUE TO SPONDYLOLISTHESIS AT L4/L5, WITH INTENDED PLACEMENT OF 9 SCREWS FOR FIXATION, THEREOF 6 PEDICLE SCREWS BILATERAL L3 TO L5, 2 SPINE SCREWS BILATERAL IN S1, AND ONE SI SCREW, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE&TRAUMA 3D 2.6. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION ATTACHED THE NAVIGATION REFERENCE ON THE SPINOUS PROCESS OF THE VERTEBRA L2. ACQUIRED AN INTRA-OPERATIVE CT SCAN WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION. VERIFIED THE REGISTRATION ACCURACY IN NAVIGATION AND ACCEPTED THE ACCURACY TO PROCEED. USED THE NAVIGATED POINTER TO PLAN THE SCREW ENTRY POINTS AND TRAJECTORIES, AND MARKED THE ENTRY POINTS WITH A NOT NAVIGATED AWL. CREATED THE PILOT HOLES WITH A NAVIGATED STRAIGHT PROBE, USING A MALLET TO APPLY THE HIGH FORCES TO OPEN THE CORTICAL BONE. THREADED THE PILOT HOLES WITH A NOT NAVIGATED NON-BRAINLAB TAP, AND PLACED THE 8 SCREWS BILATERAL IN VERTEBRAE L3 TO S1 WITH A NOT NAVIGATED NON-BRAINLAB SCREWDRIVER, FOLLOWING THE PREPARED PILOT HOLES. ACQUI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14276141 ↗
• InjuryApr 28, 2022Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE LUMBAR AND SACRAL SPINE FOR A REVISION AND EXTENSION OF A PRE-EXISTING FUSION OF VERTEBRAE L3 TO S1, DUE TO PSEUDOARTHROSIS, TO REVISE A BROKEN S1 SCREW AND TO EXTEND THE FUSION TO L2 TO THE ILIUM, WITH INTENDED PLACEMENT OF 12 SPINE SCREWS (5 NEW INCLUDING ONE NEW TRAJECTORY FOR THE BROKEN SCREW, AND 7 IN THE PRE-EXISTING PATHWAYS OF THE FORMER CONSTRUCT), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE&TRAUMA 3D 2.6. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION, EXPOSED THE COMPLETE REGION OF INTEREST OF THE SPINE, REMOVED THE EXISTING SPINE FIXATION HARDWARE AND ATTACHED THE NAVIGATION REFERENCE ON TOP OF THE CONSTRUCT ON THE SPINOUS PROCESS OF THE VERTEBRA L1. ACQUIRED AN INTRA-OPERATIVE CT SCAN WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION. VERIFIED THE REGISTRATION ACCURACY IN NAVIGATION ON THE BASE OF THE ARRAY CLAMP AND ACCEPTED THE ACCURACY TO PROCEED. USED THE NAVIGATED POINTER TO DETERMINE A SCREW TRAJECTORY IN THE SACRUM LEFT, AND PREPARED THE BONE (PILOT HOLE) BY DRILLING THOUGH THE NAVIGATED DRILL GUIDE 3.2MM. DETERMINED THAT THE DRILLED PILOT HOLE "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14236768 ↗
• InjuryApr 5, 2022Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE LUMBOSACRAL SPINE FOR A FUSION OF VERTEBRAE L4 TO S1 WITH DECOMPRESSION, THE PATIENT SUFFERING FROM SEVERE ARTHRODESIS, WITH INTENDED PLACEMENT OF 6 PEDICLE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE&TRAUMA 3D 2.6. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF VERTEBRA L5. ACQUIRED AN INTRA-OPERATIVE 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. STARTING WITH LEFT L4, USED A NAVIGATED NON-BRAINLAB STRAIGHT PROBE TO OPEN THE CORTICAL BONE CALIBRATED A NON-BRAINLAB TAP TO NAVIGATION FOR INSTRUMENT POSITION DISPLAY, AND THREADED THE PILOT HOLE. PLACED THE PEDICLE SCREW WITH A NOT NAVIGATED NON-BRAINLAB SCREWDRIVER FOLLOWING AND INTO THE THREADED PILOT HOLE. PREPARED AND PLACED THE REMAINING 5 SCREWS WITH THE SAME METHOD USING THE SAME NAVIGATED AND NOT NAVIGATED INSTRUMENTS UNTIL ALL INTENDED 6 SCREWS BILATERAL IN L4 TO S1 WERE IMPLANTED INTO THE SPINE. COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014985 ↗

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