Navigation Software Spine & Trauma 3D 2.6Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 04056481106591), received between Dec 21, 2016 and Jan 30, 2025 — classified as 83 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (101 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 103 reports, 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 ↗
• 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 ↗
• InjuryMar 14, 2022Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE LUMBOSACRAL SPINE FOR A FUSION OF VERTEBRAE L5 AND S1 WITH DECOMPRESSION, DUE TO A COMPACTED (HERNIATED) DISC BETWEEN S1 AND L5, WITH INTENDED PLACEMENT OF 4 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 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 L5, USED THE NAVIGATED POINTER TO DETERMINE THE ENTRY POINT, AND USED A NON-NAVIGATED NON BRAINLAB BURR DRILL TO OPEN THE CORTICAL BONE. CALIBRATED A NON-BRAINLAB TAP TO NAVIGATION FOR INSTRUMENT POSITION DISPLAY, AND THREADED THE PILOT HOLE. CALIBRATED A NON-BRAINLAB SCREWDRIVER TO NAVIGATION AND PLACED A PEDICLE SCREW INTO THE THREADED PILOT HOLE OF LEFT L5. OBSERVED THAT THE SCREWDRIVER'S LOCATION DISPLAY APPEARED TO BE DIFFERENT FROM THE TAP IN THE NAVIGATION. CREATED THE REMAINING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13758220 ↗
• InjurySep 6, 2021Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE THORACIC AND LUMBAR SPINE FOR AN INTERBODY FUSION OF VERTEBRAE T4 TO L5, FOR SEVERE THORACOLUMBAR SCOLIOSIS WITH INTENDED PLACEMENT OF 28 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 SURGEONS: WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF T11. ACQUIRED AN INTRA-OPERATIVE CT SCAN WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION, VERIFIED AND ACCEPTED THE REGISTRATION. PREPARED THE PEDICLES (PILOT HOLES) WITH A NON-BRAINLAB PROBE CALIBRATED TO NAVIGATION, MALLETING WAS NEEDED TO ENTER THE PROBE INTO THE BONES. THREADED THE PILOT HOLES USING A NON-BRAINLAB TAP CALIBRATED TO NAVIGATION FOR INSTRUMENT POSITION DISPLAY. THE RIGHT SIDE SURGEON USED A NON-BRAINLAB SCREWDRIVER CALIBRATED TO NAVIGATION FOR DISPLAY TO PLACE THE PEDICLE SCREWS. THE LEFT SIDE SURGEON, AFTER NAVIGATING ONLY THE PILOT HOLES AND THREADING, PERFORMED THE SCREW PLACEMENTS WITHOUT THE AID OF NAVIGATION, WITH THE SCREWDRIVER NOT NAVIGATED. WHEN NAVIGATING THE PLACEMENTS AT VERTEBRA T10, THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12427385 ↗
• InjuryApr 6, 2021Use of Device Problem; Use of Device Problem

  A SURGERY ON THE SPINE FOR LUMBAR FUSION FROM T11-L3 FOR A FRACTURE AT L1 WITH PLANNED PLACEMENT OF 8 PEDICLE SCREWS, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA 3D 2.6. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN PRONE POSITION ON THE OR TABLE. ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE RIGHT ILIAC CREST. PERFORMED AN INTRAOPERATIVE CT SCAN AND VERIFIED AND ACCEPTED THE AUTOMATIC REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION (TO THE INTRAOPERATIVE CT SCAN IMPORTED INTO AND USED BY THE NAVIGATION). CALIBRATED A NON-BRAINLAB TAP AND SCREWDRIVER TO THE NAVIGATION, AND VERIFIED AND ACCEPTED THE CALIBRATIONS TO PROCEED. USED THE NAVIGATED BRAINLAB DRILL GUIDE TO CREATE A PILOT HOLE AT LEFT T11, AND PLACED THE NAVIGATED POINTER IN THE TRACT TO CHECK THE TRAJECTORY. USED THE NAVIGATED TAP TO PREPARE THE HOLE FOR THE SCREW, AND USED THE NAVIGATED POINTER TO CHECK THE TRAJECTORY AGAIN. USED THE NAVIGATED SCREWDRIVER TO PLACE THE SCREW IN THE PREPARED HOLE AT LEFT T11. REPEATED THIS SURGICAL WORKFLOW USING THE NAVIGATED DRILL GUIDE, POINTER, TAP, AND SCREWDRIVER TO PLACE SCREWS IN RIGHT T11 AND BOTH SIDES O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11623893 ↗
• InjuryMar 2, 2021Use of Device Problem; Use of Device Problem

  A MINIMALLY INVASIVE SURGERY (MIS) ON THE SPINE FOR AN EXTREME LATERAL INTERBODY FUSION (XLIF) WITH PLANNED PLACEMENT OF BILATERAL K-WIRES AND PEDICLE SCREWS 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: POSITIONED THE PATIENT IN PRONE POSITION ON THE OR TABLE. ATTACHED THE NAVIGATION REFERENCE ARRAY SLIGHTLY LATERAL TO THE RIGHT POSTERIOR SUPERIOR ILIAC SPINE (PSIS), BY DRILLING TWO SCHANZ SCREWS INTO THE BONE TO WHICH THE 2-PIN FIXATOR AND NAVIGATION REFERENCE ARRAY WERE ATTACHED. PERFORMED A 3D FLUOROSCOPY SCAN USING A NON-BRAINLAB 3D C-ARM AND VERIFIED AND ACCEPTED THE AUTOMATIC REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION (TO THE INTRA-OPERATIVE 3D FLUOROSCOPY SCAN IMPORTED INTO AND USED BY THE NAVIGATION). DETERMINED VIA THE SCAN THAT THE SCHANZ SCREWS WERE PLACED TOO DEEP (PAST THE BONE). THE SURGEON PARTIALLY REMOVED (E.G. BACKED OUT) THE SCREWS, SO THAT THEY WERE WHOLLY CONTAINED WITHIN THE BONE, AND RE-SECURED THE NAVIGATION REFERENCE TO THE SCREWS. PERFORMED A SECOND 3D FLUOROSCOPY SCAN WITH AUTOMATIC REGISTRATION IN THE SAME MANNER AS BEFORE, AND VERIFIED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11401172 ↗
• InjuryFeb 26, 2021Use of Device Problem; Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE SPINE FOR AN L4-L5 OBLIQUE LUMBAR INTERBODY FUSION (OLIF) WITH PLANNED PLACEMENT OF TWO UNILATERAL LEFT-SIDED PEDICLE SCREWS AND AN INTERBODY CAGE, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA 3D 2.6. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN LATERAL POSITION ON THE OR TABLE. ATTACHED THE NAVIGATION REFERENCE ARRAY TO THE POSTERIOR SUPERIOR ILIAC SPINE (PSIS) DRILLING TWO SCHANZ SCREWS INTO THE BONE, TO WHICH THE BRAINLAB 2-PIN FIXATOR AND NAVIGATION REFERENCE ARRAY WERE ATTACHED. PERFORMED AN INTRAOPERATIVE CT SCAN AND VERIFIED AND ACCEPTED THE AUTOMATIC REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION (TO THE INTRA-OPERATIVE CT SCAN IMPORTED INTO AND USED BY THE NAVIGATION). CALIBRATED A NON-BRAINLAB TAP AND SCREWDRIVER TO THE NAVIGATION, AND ACCEPTED THE ACCURACY OF THE CALIBRATION TO PROCEED. CREATED A PILOT HOLE IN LEFT L4 USING THE NAVIGATED BRAINLAB DRILL GUIDE AND STORED THE TRAJECTORY OF THE DRILL GUIDE TO THE NAVIGATION. PREPARED A PATH IN THE PEDICLE OF LEFT L4 USING THE NAVIGATED NON-BRAINLAB TAP, AND PLACED THE SCREW DOWN THE PATH USING THE NAVIGATED NON-B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388724 ↗
• InjuryFeb 15, 2021Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE THORACIC-LUMBAR SPINE FOR FUSION OF VERTEBRAE T11 TO L5 DUE TO A CORONAL DEFORMITY, WITH INTENDED PLACEMENT OF 14 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 SURGEONS: ATTACHED THE NAVIGATION REFERENCE ARRAY ON VERTEBRA L5, WITH THE PATIENT IN PRONE POSITION. ACQUIRED AN INTRA-OPERATIVE (PRE-SURGERY) CT SCAN FOR THE REGION OF INTEREST OF THE SPINE WITH AUTOMATIC IMAGE REGISTRATION TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY, VERIFIED THE ACCURACY OF REGISTRATION IN THE NAVIGATION AND ACCEPTED THE REGISTRATION TO PROCEED. USED THE NAVIGATED DRILL GUIDE TO CREATE THE PILOT HOLES DRILLING THROUGH THE GUIDE TUBE, AND A NAVIGATED STRAIGHT PROBE FOR PILOT HOLE VERIFICATION. PLACED THE 14 PEDICLE SCREWS WITH A NON-BRAINLAB SCREWDRIVER CALIBRATED TO NAVIGATION BILATERALLY INTO VERTEBRAE T11-L5. PERFORMED ANOTHER INTRA-OPERATIVE CT SCAN FOR VERIFICATION, AND DETERMINED THAT AT LEAST 10 OF THE 14 PEDICLE SCREWS PLACED DEVIATED BY CA. 5MM SUPERIOR, BREACHING THE VERTEBRAE. DECIDED TO RE-PLACE/RE-POSITION THE DEVIATING SCREWS FREEHAND WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327120 ↗
• InjuryJan 27, 2021Use of Device Problem; Use of Device Problem

  A SURGERY FOR A C1-C2 SPINAL FUSION FOR A DENS FRACTURE WITH PLANNED PLACEMENT OF TWO LATERAL MASS AND TWO PEDICLE SCREWS, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA 3D 2.6. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN PRONE POSITION ON THE OR TABLE. ATTACHED THE NAVIGATION REFERENCE ARRAY ON VERTEBRA C2. PERFORMED A 3D FLUOROSCOPY SCAN USING A NON-BRAINLAB 3D C-ARM AND ACCEPTED THE AUTOMATIC REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION (TO THE INTRA-OPERATIVE 3D FLUOROSCOPY SCAN IMPORTED INTO AND USED BY THE NAVIGATION). THE SURGEON DID NOT RECALL IF HE DID A CORRECT AND COMPLETE VERIFICATION OF ACCURACY PRIOR TO ACCEPTING THE REGISTRATION. USED THE NAVIGATED BRAINLAB DRILL GUIDE TO AID IN DRILLING A PATH IN RIGHT C1, AND PLACED THE LATERAL MASS SCREW DOWN THE PATH USING A NON-NAVIGATED NON-BRAINLAB SCREWDRIVER. USED THE NAVIGATED BRAINLAB POINTER AND DETECTED A 2-3MM DEVIATION OF THE POSITION OF THE POINTER IN THE NAVIGATION DISPLAY COMPARED TO ITS ACTUAL POSITION ON THE PATIENT'S ANATOMY. PERFORMED ANOTHER 3D FLUOROSCOPY SCAN WITH AUTOMATIC REGISTRATION TO THE NAVIGATION IN THE SAME MANNER AS BEFOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11238126 ↗
• InjuryJan 25, 2021Use of Device Problem; Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE THORACIC-LUMBAR SPINE FOR POSTERIOR SPINAL FUSION (PSF) OF VERTEBRAE T11 TO L3 INCLUDING VERTEBROPLASTY AND L1 LAMINECTOMY, DUE TO A COMPRESSION FRACTURE OF VERTEBRA L1 WITH THE PATIENT'S EXISTING OSTEOPOROSIS, WITH INTENDED PLACEMENT OF 10 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 RIGHT POSTERIOR SUPERIOR ILIAC SPINE (PSIS) USING THE 2-PIN FIXATOR WITH 4X150MM SCHANZ PINS. ACQUIRED A FLUOROSCOPY SCAN USING AN INTRA-OPERATIVE C-ARM WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION, VERIFIED AND ACCEPTED THE REGISTRATION. USED THE NAVIGATED POINTER TO PLAN THE INCISIONS AND PREPARED THE PEDICLES (PILOT HOLES) BY DRILLING THROUGH THE NAVIGATED DRILL GUIDE 3.2MM, FIRST ON THE PATIENT'S LEFT SIDE FOR VERTEBRAE T11-L3 (EXCEPT L1), INSERTED AN 1.75MM K-WIRE INTO THE PEDICLE HOLES, AND PLACED THE SCREWS FOLLOWING THE K-WIRE WITH A NON-BRAINLAB SCREWDRIVER CALIBRATED TO NAVIGATION. PERFORMED ANOTHER INTRA-OPERATIVE C-ARM S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11221795 ↗
• InjuryDec 14, 2020Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  A MINIMALLY INVASIVE SURGERY (ON 16 NOV 2020) ON THE LUMBAR SPINE FOR L5/S1 FUSION WITH INTENDED PLACEMENT OF 4 K-WIRES/PEDICLE SCREWS, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA 3D 2.6. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT PRONE ON THE OR TABLE AND ATTACHED A 1-PIN FIXATOR WITH SCHANZ PIN WITH A 4-SPHERE ARRAY TO THE RIGHT ILIAC CREST - PERFORMED INITIAL PATIENT REGISTRATION (CT-FLUORO MATCHING) TO MATCH THE CURRENT PATIENT ANATOMY TO THE NAVIGATION, VERIFIED REGISTRATION ACCURACY, AND CONSIDERED IT ACCEPTABLE - PLANNED FOUR SCREW TRAJECTORIES, PREPARED THE PEDICLES AND PLACED K-WIRES USING THE NAVIGATED BRAINLAB PEDICLE ACCESS NEEDLE (PAN) - DETECTED THAT THE PAN WAS BENT AFTER HAVING PREPARED THE LAST/FOURTH PEDICLE (OF RIGHT L5) - INSERTED A CAGE - INSERTED SCREWS USING A NON-BRAINLAB TAP (UNKNOWN IF NAVIGATED) AND A NAVIGATED NON-BRAINLAB SCREWDRIVER (RELYING LESS ON NAVIGATION THAN FOR K-WIRE PLACEMENT, SINCE ANTICIPATING A POSSIBLE ANATOMICAL CHANGE DUE TO THE PRECEDING CAGE INSERTION) - OBSERVED A DEVIATION OF THE SCREWDRIVER POSITION ON NAVIGATION DISPLAY COMPARED TO ITS ACTUAL POSITION ON ANATOMY WHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11002030 ↗
• InjuryNov 26, 2020Use of Device Problem; Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON (B)(6) 2020 ON THE LUMBAR SPINE FOR FUSION OF VERTEBRAE L5 - S1 FOR SPONDYLOLISTHESIS WITH A PARS DEFECT (STRESS FRACTURE), WITH INTENDED PLACEMENT OF 4 PEDICLE SCREWS FOR FIXATION, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA 3D 2.6. (NOTE: BASED ON THE PATIENT SCAN DATA AND THE FACT THAT A REGION MATCH WAS PERFORMED ON THE BONE, THE CASE APPEARS TO HAVE PROCEEDED AS AN OPEN PROCEDURE, DESPITE A MINIMALLY INVASIVE PROCEDURE WAS LIKELY ORIGINALLY INTENDED). DURING THE PROCEDURE, THE SURGEON: POSITIONED THE PATIENT PRONE ON THE OR TABLE, AND MADE SKIN INCISIONS. PERFORMED DECOMPRESSION AT L5 - S1 (INCL. REMOVAL OF THE SPINOUS PROCESSES AT L5 - S1), AND INSERTED AN INTERBODY CAGE INTO THE DISC SPACE AT L5/S1. ATTACHED A REFERENCE CLAMP WITH A 3-SPHERE ARRAY TO THE SPINOUS PROCESS OF L4. ACQUIRED A CT SCAN, BUT COULD NOT PERFORM AUTOMATIC IMAGE REGISTRATION (OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION) DUE TO DATA TRANSFER ISSUES. PERFORMED A MANUAL PATIENT REGISTRATION USING SURFACE/REGION MATCHING ON S1 (TO MATCH THE CURRENT PATIENT ANATOMY TO THE NAVIGATION). VERIFIED THE REGISTRATION ACCURACY, DET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10910531 ↗
• InjuryNov 23, 2020Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE LUMBAR SPINE FOR DECOMPRESSION AND FUSION OF VERTEBRAE L3-S1 FOR SPONDYLOLISTHESIS, WITH INTENDED PLACEMENT OF 8 PEDICLE SCREWS FOR FIXATION, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE&TRAUMA 3D 2.6. THE PATIENT ALSO HAD 3 SYNOVIAL CYSTS THAT NEEDED TO BE REMOVED IN THE PROCEDURE AS WELL, THOUGH NO USE OF NAVIGATION AID WAS INTENDED FOR THIS PART OF THE SURGERY. THE PATIENT HAD PRE-EXISTING STABILIZATION HARDWARE IMPLANTED ON THE LUMBAR SPINE. DURING THE PROCEDURE THE SURGEON: ATTACHED THE NAVIGATION REFERENCE ARRAY ON L5, AND ACQUIRED A FLUOROSCOPY SCAN USING AN INTRA-OPERATIVE C-ARM WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION. VERIFIED THE REGISTRATION ACCURACY, USED THE NAVIGATED POINTER TO PLAN THE TRAJECTORIES AND PREPARED THE PEDICLES (PILOT HOLES) BY DRILLING THROUGH THE NAVIGATED DRILL GUIDE 3.2MM WITH DEPTH GAUGE, FIRST LEFT THEN RIGHT SIDE OF VERTEBRAE L3 AND L4. CHECKED THE PILOT HOLES WITH A NOT NAVIGATED NON-BRAINLAB FEELER, THREADED THE PILOT HOLES WITH A NOT NAVIGATED NON-BRAINLAB TAP, AND PLACED THE 4 PEDICLE SCREWS IN L3 AND L4 ALSO WITHOUT THE USE OF NAVIGATION W

  Patient problems: Numbness

  MAUDE report 10885165 ↗