Navigation Software Spine & Trauma 3D 2.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04056481000714), received between Sep 30, 2016 and May 15, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 reports).

5 other recalls cover devices cleared under the same FDA submission (K070106); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJun 14, 2019Use of Device Problem; Use of Device Problem

  AN OPEN SURGERY ON THE SPINE FOR EXTENSION OF A PRE-EXISTING POSTERIOR FUSION, TO EXTEND THE CONSTRUCT DUE TO ADJACENT SEGMENTAL DISEASE ALONG WITH ALIF AT PREVIOUSLY FUSED LEVELS, WITH PLACEMENT OF 4 PEDICLE SCREWS IN S1 AND L2 WITH ILIAC BOLTS, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE&TRAUMA 3D 2.5. A PRE-SURGERY CT SCAN TO USE WITH NAVIGATION WAS ACQUIRED 10 DAYS BEFORE THIS SURGERY. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN PRONE POSITION ON THE OPERATING ROOM TABLE. ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINE ON VERTEBRA L2. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP CT ACQUIRING REGISTRATION POINTS MOST LIKELY ON THE VERTEBRA L3 ON THE ACTUAL PATIENT'S SPINE, DESPITE THE USER APPARENTLY INTENDED TO ACQUIRE ON L2, TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE REGISTRATION AND ACCEPTED THE REGISTRATION TO PROCEED. CALIBRATED A NON BRAINLAB AWL TO THE NAVIGATION TO PREPARE THE PEDICLE HOLES IN THE VERTEBRAE. CALIBRATED A NON-BRAINLAB CANNULATED PROBE TO THE NAVIGATION TO ENTER THE PEDICLES UNDER NAVIGATION GUIDANCE. USED A NON NAVIGATED NON-BR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8698972 ↗
• InjuryDec 20, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  A MINIMAL INVASIVE SPINE SURGERY FOR SCREW PLACEMENT ON L3-L5 WAS PLANNED TO BE PERFORMED ON (B)(6) 2018 WITH THE AID OF BRAINLAB NAVIGATION SYSTEM SPINE & TRAUMA 3D VERSION 2.5. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN PRONE ORIENTATION AND ATTACHED THE NAVIGATION REFERENCE TO THE PATIENT'S ILIAC CREST. PERFORMED THE INITIAL PATIENT REGISTRATION (CT-FLUORO MATCHING REGISTRATION) TO MATCH THE VIRTUAL DISPLAY OF PREOPERATIVE CT AND FLUORO SCANS TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF REGISTRATION AND, AFTER MULTIPLE REGISTRATION ATTEMPTS, DETERMINED THE REGISTRATION ACCURACY AS APPROPRIATE FOR THE PROCEDURE. PLACED 6 K-WIRES IN VERTEBRA L3-L5 WITH THE AID OF NAVIGATION. VERIFIED THE PLACEMENT (USING C-ARM) AND DETECTED THAT 4 K-WIRES (IN L3 AND L5) WERE PLACED WITH A DEVIATION OF 5-10 MM IN CRANIAL DIRECTION FROM THE INTENDED POSITION. REMOVED AND REPLACED THE K-WIRES. PLACED 2 SCREWS IN VERTEBRA L3 WITH THE AID OF NAVIGATION. VERIFIED THE PLACEMENT (USING C-ARM) AND DETECTED THAT THE SCREWS WERE PLACED WITH A DEVIATION OF 5-10 MM FROM THE INTENDED POSITION. CONTINUED THE SURGERY WITHOUT THE AID OF NAVIGATION (USING C-ARM), INCLUDING CORRECTION OF

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8183476 ↗
• InjuryAug 27, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A SPINE SURGERY SYSTEM TO PLACE 4 SCREWS IN THE THORACIC REGION WAS PLANNED TO BE PERFORMED WITH THE AID OF BRAINLAB NAVIGATION SYSTEM SPINE AND TRAUMA 3D VERSION 2.5. DURING THE PROCEDURE THE SURGEON: ATTACHED THE NAVIGATION REFERENCE ARRAY TO THE THORACIC VERTEBRA BELOW THE TWO VERTEBRAE INTENDED TO BE INSTRUMENTED. PERFORMED AN INTRAOPERATIVE SCAN WITH THE SIEMENS ARCADIS ORBIC 3D C-ARM, THAT WAS AUTOMATICALLY MATCHED BY THE NAVIGATION SYSTEM WITH THE CURRENT PATIENT ANATOMY (AUTOMATIC IMAGE REGISTRATION) VERIFIED THE ACCURACY OF THE REGISTRATION AND DETERMINED IT TO BE APPROPRIATE. PLACED 4 SCREWS WITH THE AID OF A DRILL GUIDE AND SCREW DRIVER, BOTH CALIBRATED AND NAVIGATED WITH THE BRAINLAB NAVIGATION SYSTEM. PERFORMED A 3D SCAN FOR VERIFICATION AND DETERMINED THAT THE SCREWS WERE NOT PLACED AS INTENDED, BUT ALL SHIFTED TOWARDS THE RIGHT SIDE. THERE HAVE BEEN NO NEGATIVE CLINICAL EFFECTS FOR THIS PATIENT REPORTED TO BRAINLAB FROM THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7818252 ↗
• Sep 30, 2016Mechanical Problem; Improper or Incorrect Procedure or Method; Mechanical Problem; Improper or Incorrect Procedure or Method

  AN OPEN SPINE SURGERY ON THE VERTEBRAS C2-T2 WAS PLANNED TO BE PERFORMED WITH THE AID OF BRAINLAB NAVIGATION SYSTEM SPINE & TRAUMA 3D 2.5. DURING THE PROCEDURE THE SURGEON: FIXATED THE PATIENT'S HEAD IN A THIRD PARTY HEAD CLAMP AND ATTACHED THE NAVIGATION REFERENCE ARRAY TO THE HEAD CLAMP. PERFORMED AN AUTOMATIC IMAGE REGISTRATION (MATCHING OF VIRTUAL DISPLAY OF PATIENT IMAGE DATA AND ACTUAL PATIENT ANATOMY) IN COMBINATION WITH THE AIRO CT SCANNER. ROTATED THE PATIENT TABLE BY 90 DEGREE AND MOVED THE NAVIGATION CAMERA FROM THE FOOT TO THE HEAD SIDE OF THE TABLE. VERIFIED THE ACCURACY OF THE REGISTRATION AND DETERMINED IT TO BE APPROPRIATE. USED A NAVIGATED DRILL GUIDE TO PREPARE THE SCREW CANALS ON C2. PLACED THE SCREWS WITH A NON-NAVIGATED SCREW DRIVER. COMPLETED THE SURGERY AS PLANNED (WITHOUT FURTHER USAGE OF THE BRAINLAB NAVIGATION SYSTEM). AFTER THE SURGERY, THE SURGEON REALIZED THAT THE PLACEMENT OF THE SCREWS WAS NOT AS DESIRED. THERE HAVE BEEN NO CORRECTIVE ACTIONS PERFORMED FOR THIS SPECIFIC PATIENT AND THERE ARE NO NEGATIVE CLINICAL EFFECTS FOR THIS PATIENT DUE TO THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5989832 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070106. One submission often covers many models, so check the product and lot details in each record.

• Z-1082-2019 · Feb 27, 2019 · Terminated
  Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as a
• Z-0320-2018 · Nov 16, 2017 · Terminated
  Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
• Z-0282-2016 · May 8, 2015 · Terminated
  BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative im
• Z-2213-2014 · May 21, 2014 · Terminated
  Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe
• Z-1469-2014 · Nov 18, 2013 · Terminated
  Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264