Brainlab Elements Image Fusion 4.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04056481140816), received between Jun 13, 2020 and Feb 1, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2024Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A STEREOTACTIC NEUROSURGERY (ON (B)(6), 2023) FOR BILATERAL DEEP BRAIN STIMULATION (DBS) ELECTRODE PLACEMENT, HAS BEEN PERFORMED FOLLOWING A TREATMENT PLAN CREATED WITH THE BRAINLAB PLANNING SOFTWARE BRAINLAB ELEMENTS IMAGE FUSION 4.0.2 AND STEREOTAXY 2.5.1. THE TREATMENT PLAN CONTAINED THREE PRE-OPERATIVELY ACQUIRED MR SCANS (FUSED ACCURATELY) AND PRE-PLANNED TRAJECTORIES. DURING THE PROCEDURE THE SURGEONS: - WITH THE PATIENT ANESTHETIZED, FIXED A NON-BRAINLAB STEREOTACTIC FRAME AND LOCALIZER TO THE PATIENT'S HEAD, AND ACQUIRED AN INTRAOPERATIVE CT SCAN - FUSED IT TO THE TREATMENT PLAN'S EXISTING FUSION TREE (THE PRE-OPERATIVE MR SCANS) USING THE BRAINLAB IMAGE FUSION SOFTWARE, AND ACCEPTED THE FUSION RESULT TO PROCEED - LOCALIZED THE INTRAOPERATIVE CT SCAN FOR THE PLAN TO CALCULATE COORDINATES OF THE PLANNED TRAJECTORIES FOR THE NON-BRAINLAB STEREOTACTIC ARC USING THE BRAINLAB STEREOTAXY SOFTWARE - NOTED THE CALCULATED COORDINATES, REMOVED THE LOCALIZER BOX, POSITIONED THE PATIENT IN A BEACH CHAIR POSITION, AND ATTACHED THE NON-BRAINLAB STEREOTACTIC ARC TO THE FRAME - ALIGNED THE ARC TO THE COORDINATES FOR THE FIRST ELECTRODE (RIGHT SIDE), MADE THE INCISION AND BURR HOLE AT THE E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621092 ↗
• InjuryApr 19, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A STEREOTACTIC NEUROSURGERY FOR BILATERAL DEEP BRAIN STIMULATION (DBS) ELECTRODE PLACEMENT TO TREAT CERVICAL DYSTONIA TREMORS, WAS PERFORMED WITH A TREATMENT PLAN OF THE BRAINLAB ELEMENTS IMAGE FUSION 4.0 AND TRAJECTORY PLANNING 2.5 SOFTWARE. PLACEMENT OF TWO (BILATERAL) ELECTRODES WAS PLANNED AND PERFORMED. ONE DAY PRIOR TO THE SURGERY, A PREOPERATIVE MRI SCAN WAS USED WITH THE BRAINLAB ELEMENTS SOFTWARE TO IDENTIFY THE ENTRY AND TARGET POINTS (TRAJECTORIES) FOR THE PLANNED LEAD PLACEMENTS. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT ANESTHETIZED, FIXED A NON-BRAINLAB STEREOTACTIC FRAME AND LOCALIZER TO THE PATIENT'S HEAD, AND ACQUIRED AN INTRAOPERATIVE CT SCAN. LOCALIZED THE INTRAOPERATIVE CT SCAN FOR THE PLAN TO ESTABLISH A HEAD RING-SPECIFIC COORDINATE SYSTEM FOR CALCULATION OF ARC SETTINGS FOR THE PLANNED TRAJECTORIES, AND FUSED IT TO THE EXISTING PREOPERATIVE MRI SCAN IN THE PREOPERATIVE TREATMENT PLAN USING THE BRAINLAB IMAGE FUSION SOFTWARE, CREATING A CO-REGISTRATION OF THE INTRAOPERATIVE SCAN TO THE PREOPERATIVE SCAN, AND ACTIVELY ACCEPTED THE FUSION/CO-REGISTRATION RESULT TO PROCEED. NOTED THE COORDINATES OF THE PLANNED TRAJECTORY FROM THE BRAINLAB SOFTWARE FOR TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769187 ↗
• InjuryAug 12, 2022Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A STEREOTACTIC NEUROSURGERY FOR DEEP BRAIN STIMULATION (DBS) FOR TREATMENT OF EPILEPSY, WAS PERFORMED WITH A TREATMENT PLAN OF THE BRAINLAB ELEMENTS IMAGE FUSION 4.0 AND TRAJECTORY PLANNING 2.5 SOFTWARE. PLACEMENT OF TWO (BILATERAL) ELECTRODES WAS PLANNED AND PERFORMED. PRIOR TO THE SURGERY, PREOPERATIVE MR SCANS WERE USED WITH THE BRAINLAB ELEMENTS SOFTWARE, WITH THE SCANS FUSED, TO IDENTIFY THE ENTRY AND TARGET POINTS (TRAJECTORIES) FOR THE PLANNED LEAD PLACEMENTS. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT ANESTHETIZED, FIXED A NON-BRAINLAB STEREOTACTIC FRAME AND LOCALIZER TO THE PATIENT'S HEAD, AND ACQUIRED AN INTRAOPERATIVE SCAN. BEGAN THE UPLOAD OF DATA FROM THE (NON-BRAINLAB) INTRAOPERATIVE SCANNER TO THE NON-BRAINLAB PACS SYSTEM, AND NOTED THE PROGRESS BAR ON THE INTRAOPERATIVE SCANNER HAD STARTED BUT NOT COMPLETED THE UPLOAD. STARTED THE DOWNLOAD OF THE INTRAOPERATIVE SCAN FROM THE PACS TO THE BRAINLAB ELEMENTS SOFTWARE (AS MADE AVAILABLE BY THE PACS TO THE BRAINLAB SOFTWARE), DESPITE THE SCAN HAD NOT FULLY UPLOADED TO PACS. AFTER THE DOWNLOAD (FROM PACS TO THE BRAINLAB SOFTWARE) WAS COMPLETED, NOTED THAT THE IMPORTED SCAN ONLY CONTAINED 99 OUT OF A TOTAL OF 192 SL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218304 ↗
• InjuryJun 13, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A SRS TREATMENT FOR 2 METASTASES IN THE LEFT PARIETAL AND LEFT OCCIPITAL LOBE IN THE BRAIN, PERFORMED ON (B)(6) 2020, HAD BEEN PLANNED WITH THE AID OF BRAINLAB IMAGE FUSION 4.0 (AND BRAINLAB MULTIPLE BRAIN METS SRS 2.0). DURING PLANNING/TREATMENT THE USER: PERFORMED A RIGID FUSION OF A MR AND CT IMAGE SET (TO COMBINE THE INFORMATION CONTAINED WITHIN THE INDIVIDUAL IMAGE SETS). PROCEEDED WITH CALCULATION OF AN ELASTIC FUSION FOR THIS MR/CT FUSION PAIR (A NEW MR IMAGE SET IS GENERATED USING A DEFORMABLE REGISTRATION ALGORITHM, BY BRAINLAB CRANIAL DISTORTION CORRECTION). REVIEWED AND ACCEPTED THE RESULTING ELASTICALLY DEFORMED / DISTORTION CORRECTED MR (INCL. DISTORTION CORRECTED OBJECTS). CREATED A DOSE PLAN BASED ON THE DISTORTION CORRECTED MR AND CT IMAGE SET IRRADIATED THE METASTASES ACCORDING TO THE DOSE PLAN. SUSPECTED ON (B)(6) 2020, FOR ONE METASTASIS, A DEVIATION OF ACTUAL METASTASIS LOCATION/SIZE VS. IRRADIATED TARGET VOLUME, BY COMPARING AFOREMENTIONED IMAGE SETS AND A POST-TREATMENT MR VIA RIGID FUSION. ACCORDING TO THE HOSPITAL: THE TREATMENT WAS A SRS TREATMENT (1 FRACTION), 2 BRAIN METASTASES, 20-24 GY. ONE METASTASIS (LEFT PARIETAL) WAS NOT IRRADIATED AS INTENDED, THE

  Patient problems: Radiation Overdose; Radiation Underdose

  MAUDE report 10151378 ↗