Registration Software Fluoro 3D 1.0Recalls & reported problems
Brainlab SE · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056481140311), received between Sep 3, 2019 and Sep 3, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Paresis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2019Use of Device Problem; Use of Device Problem
AN OPEN SURGERY ON THE LUMBAR SPINE FOR A L4-L5 SPINAL STENOSIS, WITH INTENDED PLACEMENT OF 4 K-WIRES AND 4 PEDICLE SCREWS BILATERAL IN L4 AND L5, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE SPINE & TRAUMA NAVIGATION SYSTEM 3.0. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN PRONE POSITION ON THE OR TABLE. ATTACHED THE NAVIGATION REFERENCE ARRAY ON VERTEBRA L4. ACQUIRED AN INTRA-OPERATIVE (PRE-SURGERY) SCAN WITH A NON-BRAINLAB C-ARM, WITH AUTOMATIC IMAGE REGISTRATION TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE PATIENT REGISTRATION IN THE REGISTRATION SOFTWARE FLUORO 3D 1.0 (SUBPART OF THE "SPINE & TRAUMA NAVIGATION SYSTEM 3.0"), AND DETERMINED THE ACCURACY TO BE SUBOPTIMAL BUT ACCEPTABLE. ACCEPTED THE REGISTRATION TO PROCEED FOR USE WITH NAVIGATION, WITH THE BRAINLAB NAV. SW SPINE&TRAUMA 3D 2.6. USED THE NAVIGATED DRILL GUIDE 2.6MM TO OPEN THE CORTICAL BONE (PILOT HOLES), AND TO PLACE THE 4 K-WIRES (1.6MM) BILATERAL IN L4 AND L5. THE 4 PEDICLE SCREWS WERE PLACED FOLLOWING THE EXISTING K-WIRES, WITH THE NON-BRAINLAB SCREWDRIVER NOT NAVIGATED. DETERMINED FROM POST-PLACEMENT LATERAL 2D FLUORO IMAGES, THAT THE PL
Patient problems: Paresis
MAUDE report 8955917 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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