Cirq Robotic Alignment Module 56100Recalls & reported problems
Brainlab SE · Class 2
Data updated Oct 16, 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 04056481141646), received between Feb 3, 2023 and Feb 3, 2023 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2023Use of Device Problem; Use of Device Problem
A MINIMALLY INVASIVE SURGERY ON THE LUMBOSACRAL SPINE FOR A POSTERIOR FUSION OF VERTEBRAE L5 TO S1, DUE TO SPONDYLOLISTHESIS, WITH INTENDED PLACEMENT OF 4 BILATERAL K-WIRES AT L5-S1 (WITH PLANNED PEDICLE SCREW PLACEMENTS FOLLOWING THE K-WIRES), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CIRQ ROBOTIC ALIGNMENT MODULE 1.0. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE RIGHT ILIAC CREST; ACQUIRED A 3D 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 TO PROCEED; PLANNED THE 4 TRAJECTORIES FOR THE SCREW PLACEMENTS; CALIBRATED THE TISSUE PREPARATION TROCAR AND THE DRILL GUIDE TO THE NAVIGATION AND VERIFIED AND ACCEPTED THE ACCURACY OF THE CALIBRATED INSTRUMENTS TO PROCEED. ATTACHED THE NAVIGATED CIRQ TO THE OR TABLE, MANUALLY ALIGNED IT TO THE APPROXIMATE TRAJECTORY LOCATION, AND USED THE SOFTWARE'S AUTOMATIC FINE ALIGNMENT TO ALIGN THE CIRQ TO THE PLANNED TRAJECTORY FOR LEFT L5; INSERTED THE NAVIGATED TISSUE PREPARATION TROCAR THROUGH THE CIRQ ARM ALIGNED TO THE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16296677 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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