Elements Trajectory Planning 2.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056481140984), received between Feb 1, 2022 and Feb 1, 2022 — 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

Recent adverse event reports

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

• InjuryFeb 1, 2022Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR A LESION LOCATED CA. 57MM DEEP IN THE BRAIN IN THE CORPUS CALLOSUM WITH A SIZE OF CA. 12X10MM, HAS BEEN PERFORMED WITH A TREATMENT PLAN OF THE BRAINLAB ELEMENTS TRAJECTORY PLANNING VERSION 2.5. PLACEMENT OF ONE LASER FIBER WAS INTENDED AND PERFORMED, DURING THE COURSE OF THE SURGERY A BIOPSY WAS TAKEN BEFOREHAND CONFIRMING A MALIGN GLIOBLASTOMA (GBM). TWO MR SCANS AND ONE PET SCAN WERE USED WITH THE BRAINLAB PLANNING, WITH THE SCANS FUSED, TO IDENTIFY AND OUTLINE THE LESION AND PREPARE THE PLAN INCLUDING THE TRAJECTORY BEFORE THE SURGERY. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT ANESTHETIZED, FIXATED A NON-BRAINLAB STEREOTACTIC FRAME AND LOCALIZER TO THE PATIENT'S HEAD, ACQUIRED A CT SCAN AND IMPORTED IT INTO THE BRAINLAB PLANNING SYSTEM. LOCALIZED THE CT SCAN FOR THE PLAN TO ESTABLISH A HEAD RING-SPECIFIC COORDINATE SYSTEM FOR CALCULATION OF ARC SETTINGS FOR A PLANNED TRAJECTORY, AND FUSED IT TO THE EXISTING MR SCAN (BEING ALREADY FUSED WITH THE OTHER SCANS) IN THE TREATMENT PLAN. NOTED THE COORDINATES OF THE PLANNED TRAJECTORY FROM THE TRAJECTORY PLANNING SW FOR THE CORRESPONDING NON-BRAINLAB STEREOTA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13415509 ↗