Spine & Trauma 3D Navigation 1,5Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 04056481142025), received between May 19, 2020 and Sep 4, 2026 — classified as 127 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (125 reports).

3 other recalls cover devices cleared under the same FDA submission (K183605, K212245); they may or may not involve this specific model.

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 127 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026Use of Device Problem; Insufficient Device Problem Information

  An open surgery at the lumbar spine for a transforaminal lumbar interbody fusion(TLIF) at L4/L5 with decompression/laminectomy due to grade I spondylolisthesis, with the intended placements of 4 bilateral k-wires, was performed with Brainlab Spine & Trauma 3D Navigation 1.5.Following successful placement of the K-wires at left L4 and L5, a navigation inaccuracy was observed during drilling at right L4 after the drill entered soft tissue. The affected trajectory was not used for final K-wire placement, and no instrumentation was placed based on the inaccurate navigation guidance. Navigation was discontinued, and the remainder of the procedure was completed conventionally.According to the surgeon (treating clinician):Procedure continued conventionally without navigation and 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 reported problem/apparent navigation inaccuracy at this surgery,There was no actual harm/negative clinical effect to the patient resulting due to the initial trajectory deviation at right L4, also not due to the prolongation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614536 ↗
• InjuryJul 17, 2026Use of Device Problem; Insufficient Device Problem Information

  An open surgery on the lumbar spine for a fusion of vertebrae L2-L3 and L3-L4, due to degeneration of L2-L3 and L3-L4, with intended placement of 6 screws bilateral for fixation (at L2, L3 and L4), was performed with the aid of the display by the Brainlab Navigation software Spine & Trauma 3D Navigation 1.5.From an intra-operative C-arm scan, the surgeon discovered that of 3 of the 6 screws placed with Brainlab navigation involved deviated from their intended positions (at left L2, L3 and L4, all 10mm too cranial). The k-wires and screws were corrected to their intended positions with navigation at the very same surgery.According to the hospital (treating clinician): Non-removal of the screws placed in a different location than intended with Brainlab Navigation involved would potentially have led to a resulting critical/serious harm to the patient (for e.g. permanent damage/impairment), because of affecting the nerves at L2 and L3. The final outcome of the surgery was successful as intended, with all screw placements correct at the end of the surgery.Although there was a direct risk of critical harm to the patient (for e.g. permanent damage/impairment), because of the deviating pla

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25851324 ↗
• InjuryOct 15, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A MINIMALLY INVASIVE SURGERY ON THE LUMBAR AND SACRAL SPINE, FOR A PERCUTANEOUS TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) OF VERTEBRAE L5 TO S1, WITH INTENDED PLACEMENT OF 4 SPINE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA 3D NAVIGATION 1.5. AFTER PLACING 3 OF THE 4 SCREWS - BILATERAL IN VERTEBRA L5 AND IN VERTEBRA RIGHT S1 - FROM INTRA-OPERATIVE FLUORO (X-RAY) IMAGING, THE SURGEON DETERMINED THAT THE SPINE SCREWS PLACED DEVIATED FROM THEIR INTENDED POSITIONS SHIFTED BY CA. 10-15MM CRANIALLY. THE SURGEON DECIDED TO REMOVE AND TO RE-PLACE THE DEVIATING SCREWS, AS WELL AS PLACING THE REMAINING INTENDED SCREW, WITH CONVENTIONAL METHODS UNDER FLUOROSCOPIC GUIDANCE TO THEIR CORRECT POSITIONS AT THE VERY SAME SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL PLACEMENTS CORRECT AT THE END OF THE SURGERY. THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THE DEVIATING INITIAL PLACEMENTS. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 1-1.5HRS. THERE WERE FURTHER NO REMEDIAL ACTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23298573 ↗
• InjuryMay 27, 2025Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE LUMBAR SPINE FOR A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) OF VERTEBRA L3 TO A FORMER EXISTING FUSION OF VERTEBRAE L4 AND L5, DUE TO DEGENERATIVE CHANGES IN THE SEGMENT L3-L5, WITH INTENDED PLACEMENT OF 2 VERTEBRA SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA 3D NAVIGATION 1.5. FROM AN INTRA-OPERATIVE C-ARM SCAN, THE SURGEON DETERMINED THAT OF 1 OF THE 2 SPINE SCREWS PLACED, IN VERTEBRA LEFT L3, DEVIATED FROM ITS INTENDED TARGET POINT BY CA. 10MM. THE DEVIATING SCREW WAS REMOVED AND RE-PLACED TO ITS CORRECT POSITION WITH NAVIGATION 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 PLACEMENT. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING INITIAL PLACEMENT, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 20MIN. 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 22087498 ↗
• InjuryMay 14, 2025Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE LUMBAR SPINE FOR A FUSION OF VERTEBRAE L3 TO L5, DUE TO FORAMINAL STENOSIS, WITH INTENDED PLACEMENT OF 6 VERTEBRA SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA 3D NAVIGATION 1.5. FROM INTRA-OPERATIVE FLUOROSCOPY IMAGES, THE SURGEON DETERMINED THAT OF 1 OF THE 6 SPINE SCREWS PLACED WITH THE AID OF NAVIGATION, IN VERTEBRA LEFT L5, DEVIATED SHIFTED FROM ITS INTENDED POSITION. THE DEVIATING SCREW WAS REMOVED AND RE-PLACED TO ITS CORRECT POSITION, REQUIRING SEVERAL PILOT HOLE CREATION ATTEMPTS, WITH NAVIGATION 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 DUE TO THE DEVIATING INITIAL PLACEMENTS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONG OF CA. 45MIN. 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 22018552 ↗
• InjuryDec 18, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  AN OPEN SURGERY ON THE LUMBAR SPINE FOR A POSTERIOR FUSION OF VERTEBRAE L4 TO L5, DUE TO SPONDYLOLISTHESIS, 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 NAVIGATION 1.5.1. FROM INTRA-OPERATIVE FLUOROSCOPY IMAGES, THE SURGEON DISCOVERED THAT OF 1 OF THE 4 SCREWS PLACED WITH THE AID OF NAVIGATION DEVIATED FROM ITS INTENDED POSITION (AT LEFT L4, BY CA. 5MM LATERALLY FROM THE INTENDED ENTRY AND TARGET POSITION). THE DEVIATING SCREW WAS CORRECTED DURING THE SAME SURGERY WITH THE AID OF NAVIGATION. ACCORDING TO THE HOSPITAL: THE DEVIATION OF 1 OF THE 4 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 REPORTED DUE TO THE DEVIATING PLACEMENTS. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING INITIAL

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

  MAUDE report 20964445 ↗
• InjuryDec 13, 2024Use 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 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) OF VERTEBRAE L4 AND L5, WITH INTENDED PLACEMENT OF 4 VERTEBRA SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SPINE & TRAUMA 3D NAVIGATION 1.5. FROM AN INTRA-OPERATIVE VERIFICATION O-ARM SCAN, THE SURGEON DETERMINED THAT 2 SPINE SCREWS PLACED IN RIGHT L4 AND L5 WITH NAVIGATION, DEVIATED FROM THEIR INTENDED POSITIONS SHIFTED CAUDAL BY CA. 17-20MM, AND INTO THE DISC SPACES. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF 2 OF 4 SPINE SCREWS PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON WITH A VERIFICATION O-ARM SCAN BEFORE FINALIZING THE SURGERY, AND THE SCREW PLACEMENTS WERE CORRECTED TO THEIR INTENDED POSITIONS AFTER SWITCHING TO AN OPEN SURGERY APPROACH, WITH NAVIGATION AT THE VERY SAME SURGERY. 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 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924389 ↗
• InjuryNov 6, 2024Use of Device Problem; Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE LUMBAR SPINE FOR A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) OF VERTEBRAE L3 AND L4, WITH DISC DECOMPRESSION AND CAGE PLACEMENT, WITH INTENDED PLACEMENT OF 4 VERTEBRA SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SPINE & TRAUMA 3D NAVIGATION 1.5. FROM AN INTRA-OPERATIVE VERIFICATION C-ARM SCAN, THE SURGEON DETERMINED THAT THE 4 SPINE SCREWS PLACED IN L3 AND L4 WITH NAVIGATION, DEVIATED FROM THEIR INTENDED POSITIONS SHIFTED LATERALLY BY CA. 4-6MM, WITH THE SCREWS ON THE RIGHT SIDE MISSING THE VERTEBRAL BODY AT THEIR TARGET POINTS. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF SPINE SCREWS PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON WITH A VERIFICATION C-ARM SCAN BEFORE FINALIZING THE SURGERY, AND THE SCREW PLACEMENTS WERE CORRECTED TO THEIR INTENDED POSITIONS UNDER FLUOROSCOPIC GUIDANCE AT THE VERY SAME SURGERY. - 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 TO HARM A CRITICAL STRUCTURE DUE TO THE DEVIATING PLACEMENTS. - THERE WAS NO HARM NOR NEGATIVE E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619667 ↗
• InjurySep 18, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A MINIMALLY INVASIVE SURGERY, FOR A LEFT ACETABULAR FRACTURE AND PELVIC RING FIXATION AFTER A MOTOR VEHICLE ACCIDENT, WAS PERFORMED ON THE SACRAL SPINE AND ILIUM, WITH INTENDED PLACEMENT OF 1 ILIOSACRAL SCREW AT S1 AND 1 TRANS-SACRAL SCREW AT S2, WITH THE AID OF THE DISPLAY BY THE BRAINLAB SOFTWARE SPINE & TRAUMA 3D NAVIGATION 1.5. FROM AN INTRA-OPERATIVE C-ARM SCAN, THE SURGEONS DISCOVERED THAT THE SCREW AT S1 (WHICH FOLLOWED THE PATH OF A NAVIGATED GUIDE WIRE) DEVIATED FROM ITS INTENDED PATH WITH A CA. 25 MM CRANIAL SHIFT. DURING THE PROCEDURE, THE SURGEONS: - WITH THE PATIENT IN SUPINE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY TO A SCHANZ PIN INSERTED INTO THE RIGHT ANTERIOR SUPERIOR ILIAC SPINE. - DRAPED THE PATIENT AND SECURED A UNIVERSAL AUTOMATIC IMAGE REGISTRATION (UAIR) MATRIX ON TOP OF THE DRAPE. - 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. - PLANNED TRAJECTORIES FOR THE SCREWS BUT DECIDED TO PERFORM A FURTHER REDUCTION OF THE PELVIS WITHOUT NAVIGATION. - AFTERWARDS, PERFORMED ANOTHER C-ARM SCAN WITH AUTOMATIC IMAGE REGISTRATION, AND FUSED BOTH SCANS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20244616 ↗
• InjuryJul 11, 2024Use of Device Problem; Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE LUMBOSACRAL SPINE FOR AN EXCISION OF INTRASPINAL TUMOR AT L5-S1 AND POSTERIOR FUSION OF VERTEBRAE L5-S1, WITH INTENDED PLACEMENT OF 4 VERTEBRA SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SOFTWARE SPINE & TRAUMA 3D NAVIGATION 1.5.1. DURING THE PROCEDURE THE SURGEON: - WITH THE PATIENT IN PRONE POSITION ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE LEFT ILIAC CREST. - 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 BRAINLAB NAVIGATED PEDICLE ACCESS NEEDLE (PAN) WITH INSTRUMENT POSITION DISPLAY ON THE PATIENT SCAN TO DETERMINE THE TRAJECTORY AND GET ACCESS TO THE VERTEBRAL BODY THROUGH THE SKIN. - STARTING WITH LEFT S1, PLACED THE K-WIRE THROUGH THE PEDICLE ACCESS NEEDLE. - WHEN CREATING THE SECOND PILOT HOLE IN LEFT L5 USING THE SAME METHOD, DETERMINED THAT THE TRAJECTORY AND LOCATION OF THE NAVIGATED PAN DISPLAYED BY THE NAVIGATION MAY NOT MATCH ITS PHYSICAL PATH AND POSITION IN THE BONE. - ACQUIRED A FLUOROSCOPY IMA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721287 ↗
• InjuryApr 30, 2024Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE CERVICAL AND THORACIC SPINE FOR A FUSION AND DECOMPRESSION OF VERTEBRAE C7 TO T5, DUE TO A VERTEBRA T2 PATHOLOGICAL COMPRESSION FRACTURE, WITH INTENDED PLACEMENT OF 10 VERTEBRA SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SPINE & TRAUMA 3D NAVIGATION 1.5. DURING THE PROCEDURE THE SURGEON: - WITH THE PATIENT IN PRONE POSITION ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF VERTEBRA T5. - 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 NAVIGATION ACCURACY TO PROCEED. - USED THE NAVIGATED POINTER WITH INSTRUMENT POSITION DISPLAY ON THE PATIENT SCAN TO DETERMINE THE TRAJECTORY (PATH) FOR THE SCREW PLACEMENT. - CALIBRATED A NON-BRAINLAB DRILL GUIDE, A NON-BRAINLAB TAP, AND A NON-BRAINLAB SCREWDRIVER TO THE NAVIGATION FOR INSTRUMENT POSITION DISPLAY. - STARTING WITH THE VERTEBRA LEFT C7, CREATED A PILOT HOLE DRILLING THROUGH THE NAVIGATED DRILL GUIDE, THE NAVIGATED TAP TO THREAD IT, AND THE NAVIGATED SCREWDRIVER TO PLACE THE SPINE SCREW INTO THE PILOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211058 ↗
• InjuryMar 28, 2024Use 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) 2024) ON THE THORACOLUMBAR SPINE FOR FUSION OF VERTEBRAE T10-L2, DUE TO A FRACTURE AT T12, WITH INTENDED PLACEMENT OF 8 SPINE SCREWS BILATERALLY FOR FIXATION (AT T10, T11, L1, L2), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA 3D NAV 1.5.1. DURING THE PROCEDURE THE SURGEON: - WITH THE PATIENT IN PRONE POSITION ATTACHED THE NAVIGATION REFERENCE ARRAY TO THE SPINOUS PROCESS OF L3. - ACQUIRED AN INTRA-OPERATIVE 3D 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 - PLACED SCREWS AT T10-L2 USING THE FOLLOWING METHOD: USED THE NAVIGATED BRAINLAB POINTER TO DETERMINE THE SCREW ENTRY POINT, USED A NON-NAVIGATED DRILL TO MARK THE ENTRY POINT AND CREATE A DIVOT TO PREVENT SKIVING, USED THE NAVIGATED BRAINLAB DRILL GUIDE TO CREATE THE PILOT HOLE, USED A NAVIGATED NON-BRAINLAB TAP TO THREAD THE PILOT HOLE, AND USED A NAVIGATED NON-BRAINLAB SCREWDRIVER TO PLACE THE SCREW. - AFTER COMPLETING SCREW PLACEMENTS AT T10 AND T11, VERIFIED NAVIGATION ACCURACY AND DETERMINED IT ACCURATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18993117 ↗
• InjuryFeb 29, 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 LUMBAR SPINE FOR LAMINECTOMIES AND FUSION OF VERTEBRAE L4-5, DUE TO SPONDYLOLISTHESIS, WITH INTENDED PLACEMENT OF AN INTERBODY CAGE AND 4 SPINE SCREWS BILATERALLY FOR FIXATION (AT L4-5), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA 3D NAV 1.5. DURING THE PROCEDURE THE SURGEON: - WITH THE PATIENT IN PRONE POSITION ACQUIRED A C-ARM SCAN TO LOCALIZE AND MAKE A MEDIAL INCISION AT THE REGION OF INTEREST. - PERFORMED LAMINECTOMIES AT L4 AND L5 THROUGH THE MEDIAL INCISION BEFORE PLACING AN INTERBODY CAGE BETWEEN THOSE VERTEBRAE. - ATTACHED THE NAVIGATION REFERENCE ARRAY TO THE CAUDAL END OF THE L3 SPINOUS PROCESS AND THE TISSUE BETWEEN L3 AND L4 SPINOUS PROCESSES. - ACQUIRED AN INTRA-OPERATIVE 3D 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 A BRAINLAB POINTER TO DETERMINE THE LOCATION FOR SCREWS TO BE PLACED ON THE PATIENT'S LEFT SIDE AND MADE A LEFT LATERAL INCISION. - CALIBRATED A NON-BRAINLAB TAP TO THE NAVIGATION FOR INSTRUMENT POSITION DISPLAY ON THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18806228 ↗
• InjuryFeb 29, 2024Use 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) 2024) ON THE LUMBAR SPINE FOR FUSION OF L4-S1, WITH INTENDED PLACEMENT OF 6 SPINE SCREWS BILATERALLY (AT L4-S1), FOR PAIN MANAGEMENT OF A PATIENT WITH A MEDICAL HISTORY OF MS DISEASE, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE& TRAUMA 3D NAV. 1.5.1: DURING THE PROCEDURE THE SURGEONS: - WITH THE PATIENT IN PRONE POSITION ATTACHED THE NAVIGATION REFERENCE ARRAY TO 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 - PLACED SCREWS AT L4, L5, AND S1 (LEFT SIDE FIRST, THEN RIGHT SIDE) AS FOLLOWS: -- USED THE BRAINLAB POINTER WITH INSTRUMENT POSITION DISPLAY ON THE PATIENT SCAN TO DETERMINE THE SCREW TRAJECTORY IN THE VERTEBRA -- USED A NAVIGATED NON-BRAINLAB AWL TO OPEN THE CORTICAL BONE, AND USED A NAVIGATED NON-BRAINLAB FLAT PROBE TO CANNULATE (ADDITIONALLY USED THE POINTER AND TWO OTHER NAVIGATED NON-BRAINLAB PROBES TO VERIFY LOCATION OF THE ENTRY/PILOT HOLE) -- USED A NON-NAVIGATED NON-BRAINLAB SCREWDRIVER TO PLACE THE SPINE SCREW INT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18806054 ↗
• InjuryFeb 15, 2024Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE LUMBAR SPINE, WITH INTENDED PLACEMENT OF 6 SPINE SCREWS BILATERALLY (AT L3-5), FOR AN EXTENSION OF FUSION FROM L3-5 (INCLUDING A REPLACEMENT OF PRE-EXISTING SPINE SCREWS AT L4-5), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SOFTWARE SPINE & TRAUMA 3D NAVIGATION 1.5. DURING THE PROCEDURE THE SURGEON: - WITH THE PATIENT IN PRONE POSITION ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE RIGHT ILIAC CREST WITH TWO SCHANZ PINS. - ACQUIRED AN INTRA-OPERATIVE 3D 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 AT VERTEBRA LEFT L3, USED A NAVIGATED DRILL GUIDE WITH INSTRUMENT POSITION DISPLAY ON THE PATIENT SCAN TO DETERMINE THE SCREW TRAJECTORY IN THE VERTEBRA. - PREPARED THE PEDICLE BY DRILLING A PILOT HOLE THROUGH THE NAVIGATED DRILL GUIDE. - CALIBRATED A NON-BRAINLAB TAP TO THE NAVIGATION FOR INSTRUMENT POSITION DISPLAY ON THE PATIENT SCAN AND THREADED THE PILOT HOLE. - CALIBRATED A NON-BRAINLAB SCREWDRIVER TO THE NAVIGATION AND SECURED THE SPINE SCREW IN THE THREADED PILOT HOLE. - MAINTAINED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710220 ↗
• InjuryJan 12, 2024Use of Device Problem; Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE LUMBARSACRAL SPINE FOR A FUSION OF VERTEBRAE L4 TO S1, DUE TO INTERVERTEBRAL OSTEOCHONDROSIS IN THE L4-S1 SEGMENTS, WITH INTENDED PLACEMENT OF 6 SPINE SCREWS BILATERAL L4-S1 FOR FIXATION, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE&TRAUMA 3D 1.5. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY TO THE RIGHT PELVIC CREST, ON 2 SCHANZ PINS PLACED INTO THE PELVIC BONE. 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. ACCEPTED THE ACCURACY TO PROCEED WITH NAVIGATION. STARTING WITH LEFT L4, USED THE NAVIGATED DRILL GUIDE 3.2MM WITH INSTRUMENT POSITION DISPLAY ON THE PATIENT SCAN TO CHECK THE NAVIGATION ACCURACY AND TO CREATE THE PILOT HOLE IN THE VERTEBRA BY DRILLING THROUGH THE NAVIGATED DRILL GUIDE. AFTER CREATING 4 PILOT HOLES WITH THIS NAVIGATED METHOD BILATERAL IN VERTEBRAE L4 AND L5, RE-CHECKED THE ACCURACY OF THE PILOT HOLES WITH THE NAVIGATED POINTER AND INSERTED K-WIRES INTO THE PILOT HOLES. PLACED 2 OF THE SPINE SCREWS WITH A NOT NAVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501926 ↗
• InjuryNov 10, 2023Use of Device Problem; Use of Device Problem

  A OPEN SURGERY ON THE CERVICAL AND THORACIC SPINE FOR A FUSION OF VERTEBRAE C4 TO T2, DUE TO A FRACTURE AT C7, WITH INTENDED PLACEMENT OF 8 SCREWS BILATERAL FOR FIXATION (AT C5, C6, T1 AND T2), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA 3D NAV 1.5. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE PATIENT'S HEAD CLAMP. 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 AND ROUGHLY PLANNED THE INCISION WITH THE AID OF NAVIGATION. DRAPED THE PATIENT AND ACQUIRED AN INTRA-OPERATIVE C-ARM SCAN OF THE PATIENT'S REGION OF INTEREST WITH AUTOMATIC IMAGE REGISTRATION. VERIFIED THE REGISTRATION AND DETERMINED THE ACCURACY AS NOT SUFFICIENT TO PROCEED AGAIN 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, DETERMINED THAT THERE IS STILL A DEVIATION OF THE NAVIGATION DISPLAY COMPARED TO THE ACTUAL PATIENT ANATOMY BY 1-2 MM, BUT DECIDED TO PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18109724 ↗
• InjuryNov 9, 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 SEP 25, 2023) ON THE LUMBAR SPINE FOR A FUSION OF VERTEBRAE L3/L4, WITH INTENDED PLACEMENT OF 4 PEDICLE SCREWS, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SPINE&TRAUMA 3D NAVIGATION 1.5.1. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT PRONE, ACQUIRED X-RAYS TO DETERMINE INCISION START POINT, PERFORMED INCISION AND DISSECTION. - ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF VERTEBRA L1 - 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 REGISTRATION ACCURACY, AND ACCEPTED THE ACCURACY TO PROCEED. - PLACED PEDICLE SCREWS AT RIGHT L3, RIGHT L4, LEFT L3, LEFT L4: DETERMINED THE ENTRY POINT USING THE BRAINLAB POINTER, PREPARED THE PEDICLE (PILOT HOLE) BY DRILLING THROUGH THE NAVIGATED BRAINLAB DRILL GUIDE, THREADED THE PILOT HOLE USING A NAVIGATED NON-BRAINLAB TAP, AND SUBSEQUENTLY PLACED THE PEDICLE SCREW USING A NAVIGATED NON-BRAINLAB SCREWDRIVER. - PERFORMED DECOMPRESSION AT L3/L4, AND PLACED CAGES AND RODS/CAPS (WITHOUT AID OF NAVIGATION). - ACQUIRED A VERIFICATION X-RAY TO CONFIRM SCREW PL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102771 ↗
• InjuryOct 27, 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 (B)(6), 2023) ON THE LUMBAR SPINE FOR AN EXTREME LATERAL INTERBODY FUSION (XLIF) OF VERTEBRAE L4/L5, DUE TO LOW GRADE SPONDYLOLISTHESIS AT L3-L5, WITH INTENDED PLACEMENT OF 4 PEDICLE SCREWS, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SPINE&TRAUMA 3D NAVIGATION 1.5. 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 REGISTRATION ACCURACY, AND ACCEPTED THE ACCURACY TO PROCEED SAVED SCREW TRAJECTORIES USING THE NAVIGATED DRILL GUIDE, AND MARKED THE INCISION POINTS FOR LEFT-SIDED PEDICLE SCREWS FOR LEFT L4 AND LEFT L5, PREPARED THE PEDICLE (PILOT HOLE) BY DRILLING THROUGH THE NAVIGATED DRILL GUIDE, PLACED A K-WIRE THROUGH THE DRILL GUIDE INTO THE PREPARED PILOT HOLE, THREADED THE PILOT HOLE FOLLOWING OVER THE K-WIRE USING A NAVIGATED NON-BRAINLAB TAP, AND SUBSEQUENTLY PLACED THE PEDICLE SCREW USING A NAVIGATED NON-BRAINLAB SCREWDRIVER. VERIFIED REGISTRATION ACCURACY USING THE POINT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18023537 ↗
• InjuryOct 24, 2023Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE SPINE FOR A REVISION (EXTENSION) OF A LUMBAR FUSION OF VERTEBRAE L3 TO L5, DUE TO A SPONDYLOLISTHESIS L3/L4, WITH AN EXISTING FORMER FUSION OF L4 AND L5 WITH INTENDED PLACEMENT OF 2 NEW VERTEBRA SCREWS BILATERAL IN L3, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SW SPINE&TRAUMA 3D 1.5. DURING THE PROCEDURE THE SURGEONS: - WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF VERTEBRA T10. - 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 RIGHT L3, USED THE NAVIGATED POINTER WITH INSTRUMENT POSITION DISPLAY ON THE PATIENT SCAN TO DETERMINE THE ENTRY POINT AND SCREW TRAJECTORY IN THE VERTEBRA. - OPENED THE VERTEBRA'S CORTICAL BONE AND CREATED THE PILOT HOLE WITH THE NAVIGATED POINTER AND A NOT NAVIGATED NON-BRAINLAB PROBE, MALLETING BOTH INSTRUMENTS INTO THE BONE. - WITHOUT USING NAVIGATION, ONLY FOLLOWING THE PILOT HOLE CREATED, TAPPED IT AND PLACED A SPINE SCREW WITH NON-BRAINLAB INSTRUMENTS. - WH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993720 ↗
• InjuryOct 19, 2023Use of Device Problem; Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE SPINE FOR A THORACO-LUMBAR FUSION OF VERTEBRAE T8 TO L2, DUE TO A FRACTURE AT T10, WITH INTENDED PLACEMENT OF 10 VERTEBRA SCREWS BILATERAL, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SW SPINE&TRAUMA 3D 1.5. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF VERTEBRA T9. ACQUIRED AN INTRA-OPERATIVE C-ARM SCAN OF THE PATIENT'S UPPER HALF 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 T8, USED THE NAVIGATED POINTER WITH INSTRUMENT POSITION DISPLAY ON THE PATIENT SCAN TO DETERMINE AND PRE-PLAN THE INCISION AND SCREW TRAJECTORY IN THE VERTEBRA. CALIBRATED A NON-BRAINLAB SCREWDRIVER, AFTER ATTACHING AN INSTRUMENT REFERENCE ARRAY TO IT, TO THE NAVIGATION FOR INSTRUMENT POSITION DISPLAY ON THE PATIENT SCAN. USED THE NAVIGATED NON BRAINLAB SCREWDRIVER WITH A CANNULATED SCREW CONTAINING A K-WIRE WITH ITS TIP EXTENDING FROM THE SCREW, MALLETING THE SCREWDRIVER TO OPEN THE CORTICAL BONE OF THE VERTEBRA AND INSERTING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17964828 ↗
• InjuryOct 12, 2023Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE LUMBAR SPINE FOR A POSTERIOR FUSION OF VERTEBRAE L3 TO L5, DUE TO DEGENERATIVE SPINE, WITH INTENDED PLACEMENT OF 6 VERTEBRA SCREWS BILATERAL, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SW SPINE&TRAUMA 3D 1.5. DURING THE PROCEDURE THE SURGICAL STAFF AND 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. ATTACHED AN INSTRUMENT REFERENCE ARRAY TO A NON-BRAINLAB HIGH SPEED BURR DRILL AND CALIBRATED IT TO THE NAVIGATION FOR INSTRUMENT POSITION DISPLAY ON THE PATIENT SCAN. CALIBRATED ALSO A NON-BRAINLAB STRAIGHT SHARP SPINE PROBE, AFTER ATTACHING AN INSTRUMENT REFERENCE ARRAY TO IT, TO THE NAVIGATION. STARTING WITH LEFT L3, USED THE NAVIGATED NON-BRAINLAB BURR DRILL TO OPEN THE CORTICAL BONE, AND FURTHER THE NAVIGATED NON-BRAINLAB PROBE TO CREATE THE PILOT HOLE AS PATH FOR THE SPINE SCREW. WHEN CREATING THIS FIRST PILOT HOLE WITH THE PROBE DISPLAYE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919394 ↗
• InjurySep 19, 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 (B)(6) 2023) ON THE LUMBAR SPINE FOR AN EXTREME LATERAL INTERBODY FUSION (XLIF) OF VERTEBRAE L4/L5, DUE TO L4 SLIP-DISC, WITH INTENDED PLACEMENT OF 4 PEDICLE SCREWS, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SPINE&TRAUMA 3D NAVIGATION 1.5. DURING THE PROCEDURE THE SURGEON: - WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY (3-SPHERE ARRAY) ON THE SPINOUS PROCESS OF VERTEBRA L4. - ACQUIRED AN INTRA-OPERATIVE 3D FLUOROSCOPIC SCAN OF THE PATIENT'S REGION OF INTEREST WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION. - AT RIGHT L4, FOR VERIFICATION OF REGISTRATION ACCURACY PALPATED BONE USING THE NAVIGATED BRAINLAB PEDICLE ACCESS NEEDLE (PAN) AND CONSIDERED REGISTRATION ACCURATE. - CREATED A PILOT HOLE USING THE PAN AND A NON-BRAINLAB MALLET, AND PLACED A K-WIRE THROUGH THE GUIDE TUBE OF THE PAN INTO THE PILOT HOLE. - AT RIGHT L5, VERIFIED REGISTRATION ACCURACY, CREATED THE PILOT HOLE, AND PLACED THE K-WIRE USING THE SAME METHOD AS BEFORE. - AT LEFT L4, BROUGHT THE PAN TO THE BONE, AND DETECTED A DEVIATION OF INSTRUMENT POSITION DISPLAYED BY NAVIGATION FROM ITS ACTUAL POSITION O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772291 ↗
• InjuryAug 17, 2023Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE CERVICAL AND THORACIC SPINE FOR A FUSION OF VERTEBRAE C7-T11, DUE TO UPPER EXTREMITY PAIN AND WEAKNESS, WITH INTENDED PLACEMENT OF 4 PEDICLE SCREWS BILATERAL FOR FIXATION (AT C7 AND T1), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE&TRAUMA 3D 1.5 A PRE-OPERATIVE CT SCAN ACQUIRED ON (B)(6) 2023 WAS USED TO REFERENCE THE NAVIGATION DISPLAY TO. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF VERTEBRA C6. PERFORMED THE INITIAL PATIENT REGISTRATION TO THE PRE-OPERATIVE CT SCAN ACQUIRING REGISTRATION POINTS ON THE BONY SURFACE OF THE PATIENT'S C7 VERTEBRA WITH THE NAVIGATED BRAINLAB POINTER TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE REGISTRATION AND DETERMINED THE ACCURACY AS NOT SUFFICIENT TO PROCEED. IMPROVED THE REGISTRATION BY ACQUIRING ADDITIONAL REFERENCE POINTS, VERIFIED THE REGISTRATION RESULT AGAIN AND ACCEPTED THE ACCURACY TO PROCEED. MADE THE PILOT HOLE FOR THE RIGHT C7 WITH A NAVIGATED NON-BRAINLAB PROBE, CHECKED THE BONE CONTACT WITH A BALL TIP PROBE TO MAKE SURE IT IS A SOLID PILOT HOLE,

  Patient problems: Neuropathy

  MAUDE report 17563504 ↗
• InjuryJul 5, 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 (B)(6) 2023) ON THE THORACIC SPINE FOR STABILIZATION OF T5-T10, DUE TO A FRACTURE AT T7/T8, FOR A PATIENT WITH COMPLETE PARAPLEGIA, WITH INTENDED PLACEMENT OF 10 PEDICLE SCREWS FOR FIXATION, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SPINE & TRAUMA 3D NAVIGATION SOFTWARE 1.5. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY TO THE SPINOUS PROCESS OF T7 (JUST POSTERIOR TO THE FRACTURE). ACQUIRED AN INTRAOPERATIVE CT SCAN WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION, VERIFIED AND ACCEPTED THE ACCURACY OF THE REGISTRATION TO PROCEED. PLACED 10 SCREWS AT T 5/6/8/9/10 USING A NAVIGATED NON-BRAINLAB SCREWDRIVER, AND VERIFIED SCREW PLACEMENT WITH A LATERAL X-RAY FOR EACH SCREW. ACQUIRED A CT VERIFICATION SCAN AND DETECTED THAT THE SCREWS WERE NOT PLACED AS INTENDED (LATERAL DEVIATION OF REPORTEDLY 5-8 MM, PARTLY THROUGH SPINAL CANAL) REPLACED ALL SCREWS CONVENTIONALLY WITHOUT AID OF NAVIGATION (USING TWO C-ARCS). ACCORDING TO THE HOSPITAL/SURGEON: THE MISPLACED SCREWS WERE DETECTED WITH A CT SCAN DURING THE SURGERY, AND WERE REPLACED (REPOSITIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17257838 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183605, K212245. One submission often covers many models, so check the product and lot details in each record.

• Z-2925-2020 · Aug 20, 2020 · Terminated
  Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)
• Z-2792-2020 · Jul 16, 2020 · Terminated
  BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
• Z-2793-2020 · Jul 16, 2020 · Terminated
  BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655