Brainlab Elements - Trajectory Planning 2.6Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056481142674), received between Jul 3, 2026 and Jul 3, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2026Use of Device Problem

  A CRANIAL SURGERY FOR TWO DEPTH ELECTRODE PLACEMENTS IN THE BRAIN, TO THE SUBSTANTIA NIGRA WITH DEPTHS OF CA. 72MM FROM THE LEFT AND CA. 77MM FROM THE RIGHT, TO TREAT PARKINSON'S DISEASE WITH DEEP BRAIN STIMULATION (DBS), HAS BEEN PLANNED WITH THE BRAINLAB ELEMENTS - TRAJECTORY PLANNING 2.6 FOR THE ELECTRODE POSITIONS, TO PLACE THEM WITH A NON-BRAINLAB STEREOTACTIC ARC/FRAME. FROM EVALUATING THE PLACED ELECTRODES WITH AN INTRA-OPERATIVE CT SCAN DURING THE SURGERY, THE SURGEON DETERMINED THAT BOTH ELECTRODES WERE PLACED IN A PATH DEVIATING SHIFTED CA. 3.5MM FROM THE PLANNED/INTENDED TRAJECTORY. THE SURGEON ALSO EVALUATED AND DETERMINED THAT THE POSITIONS OF THE ELECTRODES ARE STILL SUITABLE FOR SUCCESSFUL TREATMENT, WITHOUT ANY CHANGES, AT THE SAME SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH NO CHANGES TO THE PLANNED PROCEDURE. THERE WAS NO DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO THE DEVIATING PLACEMENTS. THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENTS, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION (FOR EVALUATION) OF CA. 20MIN. THERE WERE NO REMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25703690 ↗
• InjuryJul 3, 2026Use of Device Problem

  A CRANIAL SURGERY FOR TWO DEPTH ELECTRODE PLACEMENTS IN THE BRAIN, TO THE SUBSTANTIA NIGRA WITH DEPTHS OF CA. 79MM FROM THE LEFT AND CA. 82MM FROM THE RIGHT, TO TREAT PARKINSON'S DISEASE WITH DEEP BRAIN STIMULATION (DBS), HAS BEEN PLANNED WITH THE BRAINLAB ELEMENTS - TRAJECTORY PLANNING 2.6 FOR THE ELECTRODE POSITIONS, TO PLACE THEM WITH A NON-BRAINLAB STEREOTACTIC ARC/FRAME. FROM EVALUATING THE PLACED ELECTRODES WITH AN INTRA-OPERATIVE CT SCAN DURING THE SURGERY, THE SURGEON DETERMINED THAT BOTH ELECTRODES WERE PLACED IN A PATH DEVIATING SHIFTED CA. 4MM FROM THE PLANNED/INTENDED TRAJECTORY. THE SURGEON DECIDED TO PLACE THE ELECTRODES IN A CORRECTED POSITION, USING THE EXISTING BURR HOLES, SUCCESSFULLY AT THE SAME SURGERY WITH NO FURTHER CHANGES TO THE EXISTING SURGICAL INVASIVE ACTIONS. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH THE ELECTRODES IN CORRECT POSITIONS. THERE WAS NO DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO THE DEVIATING PLACEMENTS. THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENTS, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 45MIN. THER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25703103 ↗