Spine & Trauma 3D Navigation 1.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04056481140328), received between Aug 21, 2019 and May 17, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (4 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Feb 27, 2019Terminated

   In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image reconstruction (the not-updated ACS view ), instead of displaying the desirable view representation Inline View , which is commonly used for navigating invasive instruments at the spine. This could lead the surgeon to be unable to determine the position of the navigated instrument. This might occur after a crash restore or after changing between different navigation workflows during the same patient treatment.

   Z-1082-2019 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 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 WITH INTENDED PLACEMENT OF 8 BILATERAL PEDICLE SCREWS FOR A FUSION/STABILIZATION OF VERTEBRAE T10 - L2 FOR A VERTEBRA FRACTURE AT T12, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SPINE & TRAUMA 3D SW NAVIGATION 1.0. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY TO THE SPINOUS PROCESS OF L3. ACQUIRED A FLUOROSCOPY SCAN USING AN INTRA-OPERATIVE C-ARM WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION, AND VERIFIED AND ACCEPTED THE ACCURACY OF THE REGISTRATION TO PROCEED. CALIBRATED A NON-BRAINLAB CURVED PEDICLE PROBE TO THE NAVIGATION, AND VERIFIED AND ACCEPTED THE ACCURACY OF THE CALIBRATION TO PROCEED. CALIBRATED A NON-BRAINLAB SCREWDRIVER TO THE NAVIGATION; THE NAVIGATION DISPLAYED A MESSAGE THAT THE ACCURACY OF THE INSTRUMENT COULD BE IMPROVED, WITH SUGGESTIONS TO IMPROVE THE ACCURACY AND THE OPTIONS TO RECALIBRATE OR IGNORE; THE SURGEON CHOSE "IGNORE" TO PROCEED WITHOUT FURTHER CALIBRATION ACTIONS, AND ACCEPTED THE ACCURACY OF THE SCREWDRIVER TO PROCEED. PREPARED THE INITIAL PATH IN THE PEDICLE USING THE NAVIGATED CURVED PEDICLE PROBE FOR T10

  Patient problems: Post Operative Wound Infection

  MAUDE report 16946834 ↗
• InjurySep 23, 2021Use 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 SPINE FOR AN L5-S1 FUSION, 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 1.5. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT SUPINE AND PERFORMED AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) INCLUDING CAGE AND ANTERIOR SCREW PLACEMENT WITHOUT THE USE OF NAVIGATION. POSITIONED THE PATIENT IN PRONE POSITION AND ATTACHED THE BRAINLAB REFERENCE ARRAY TO A NON-BRAINLAB ONE-PIN FIXATOR WHICH WAS PINNED TO THE PATIENT'S LEFT ILIAC CREST. ACQUIRED A 3D FLUOROSCOPIC SCAN USING AN INTRA-OPERATIVE C-ARM WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION, AND ACCEPTED THE REGISTRATION TO PROCEED WITHOUT PERFORMING THE NECESSARY ACCURACY VERIFICATION. CALIBRATED THE BRAINLAB PEDICLE ACCESS NEEDLE AND A NON-BRAINLAB SCREWDRIVER TO THE NAVIGATION, AND PLANNED AND STORED SCREW TRAJECTORIES IN THE NAVIGATION SOFTWARE. NAVIGATED THE PEDICLE ACCESS NEEDLE TO THE PLANNED TRAJECTORY, PREPARED THE SCREW PATH, INSERTED A K-WIRE, AND THEN USED THE NAVIGATED SCREWDRIVER TO PLACE THE SCREW OVER THE K-WIRE INTO THE PEDICLE FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12522201 ↗
• InjuryFeb 6, 2020Use of Device Problem; Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE SPINE FOR FUSION OF LUMBAR VERTEBRAE L3-L4 AND ILIUM FOR FRACTURED L5, WITH INTENDED PLACEMENT OF 6 PEDICLE SCREWS BILATERAL, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE&TRAUMA 3D 1.0. DURING THE PROCEDURE THE SURGEON: ATTACHED THE NAVIGATION REFERENCE ARRAY ON S1 WITH PATIENT IN PRONE POSITION. PERFORMED A FLUOROSCOPY SCAN USING AN INTRA-OPERATIVE C-ARM WITH AUTOMATIC REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION. USED THE NAVIGATED DRILL GUIDE 3.2MM TO GUIDE THE DRILLING OF THE PILOT HOLE AND INSERTION OF THE 1.8MM K-WIRE INTO L3 RIGHT SIDE. VERIFIED THIS FIRST PLACEMENT WITH A FLUORO SHOT (X-RAY) AND DETERMINED THAT THE K-WIRE DEVIATED BY CA. 3MM AND AN ANGULATION OF CA. 10-12DEG FROM THE INTENDED POSITION. DECIDED TO ABANDON THE USE OF NAVIGATION, AND CORRECTED THE K-WIRE POSITION UNDER FLUOROSCOPIC GUIDANCE. CONTINUED TO PLACE THE REMAINING K-WIRES UNDER FLUOROSCOPIC GUIDANCE, INSERTED THE PEDICLE SCREWS FOLLOWING THE K-WIRE POSITIONS, AND COMPLETED THE SURGERY SUCCESSFULLY. ACCORDING TO THE SURGEON: THE DEVIATION OF THE K-WIRE WAS DETECTED BY THE SURGEON DIRECTLY AFTER PLACEMENT AND WA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9675729 ↗
• InjuryAug 21, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  WHAT IS THE ISSUE? AN OPEN SURGERY ON THE SPINE TO FUSE VERTEBRAE L4 AND L5 FOLLOWING THE INDICATION OF A SPINAL CANAL STENOSIS WITH PLANNED PLACEMENT OF 4 PEDICLE SCREWS, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA 3D NAVIGATION 1.0. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN PRONE POSITION ON THE OPERATING ROOM TABLE. ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF VERTEBRA L2. 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). USED A NAVIGATED AWL AND NON-NAVIGATED NON-BRAINLAB PROBE AND SCREWDRIVER TO PLACE TWO PEDICLE SCREWS IN L4 AND L5. PERFORMED AN INTRAOPERATIVE FLUOROSCOPIC CONFIRMATION SCAN USING THE NON-BRAINLAB 3D C-ARM AND DETERMINED THE TWO L5 PEDICLE SCREWS WERE MISPLACED, CRANIALLY 1 TO 1.3CM INTO THE DISC SPACE. MOVED THE NAVIGATION REFERENCE ARRAY AND ATTACHED IT IN BETWEEN THE SPINOUS PROCESSES OF L3 AND L4 (INTERSPINOUS LIGAMENT). PERFORMED ANOTHER 3D FLUOROSCOPY SCAN USING THE NON-

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915616 ↗