Navigation Software Spine & Trauma 2D Installer 3.3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056481137915), received between Mar 26, 2025 and Mar 26, 2025 — 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2025Use of Device Problem; Use of Device Problem

  A MINIMALLY INVASIVE SURGERY, FOR A SACROILIAC JOINT FUSION, WAS PERFORMED, WITH INTENDED PLACEMENT OF 2 SCREWS, WITH THE AID OF THE DISPLAY BY THE BRAINLAB SOFTWARE SPINE & TRAUMA 2D 3.3. FROM AN INTRA-OPERATIVE VERIFICATION SCAN, THE SURGEONS DISCOVERED THAT A K-WIRE PLACED AT SAI1 DEVIATED FROM ITS INTENDED PATH WITH A CA. 2 CM SHIFT. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF ONE K-WIRE PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY, AND THE K-WIRE WAS CORRECTED TO ITS INTENDED POSITION AT THE VERY SAME SURGERY. THE FINAL OUTCOME OF THE SURGERY WAS NOT SUCCESSFUL AS INTENDED, WITH ONLY ONE SCREW PLACEMENT AT THE END OF THE SURGERY INSTEAD OF TWO. THERE WAS NO DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO THE DEVIATING K-WIRE PLACEMENT. THERE WAS NEITHER HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENT. THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699508 ↗