Iplan Stereotaxy 3Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04056481000646), received between Oct 17, 2016 and Feb 17, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2023Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A DEEP BRAIN STIMULATION HAS BEEN PERFORMED FOLLOWING A TREATMENT PLAN CREATED WITH THE BRAINLAB PLANNING SOFTWARE IPLAN STEREOTAXY 3.0. DURING THE PROCEDURE THE SURGEON: 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. THE USER LOADED THIS SCAN WITH LOCALIZER INTO A FORMERLY EXISTING TREATMENT PLAN OF LAST YEAR FOR THIS PATIENT. PLANNED A TRAJECTORY FOR THE INTENDED ELECTRODE PLACEMENT INTO THE PATIENT'S BRAIN, AND USED THE CALCULATED COORDINATES OF THE PLANNED TRAJECTORY FROM THE IPLAN STEREOTAXY PLANNING SW FOR THE CORRESPONDING NON-BRAINLAB STEREOTACTIC ARC SETTINGS. APPLIED THESE COORDINATES TO THE STEREOTACTIC ARC MOUNTED ON THE STEREOTACTIC FRAME, CREATED A BURR HOLE IN THE PATIENT'S SKULL AND PLACED THE ELECTRODE WITH THE STEREOTACTIC ARC INTO THE PATIENT'S BRAIN. WHEN THE PATIENT EXPERIENCED TREMORS, ACQUIRED AN INTRA-OPERATIVE O-ARM SCAN, AND DETERMINED THAT THE ELECTRODE WAS PLACED IN A DIFFERENT LOCATION THAN INTENDED. BROUGHT THE PATIENT TO THE CT ROOM, AND A NEW CT SCAN WITH LOCALIZER MOUNTED WAS PERFORMED. IMPORTED THIS NEW SCAN AND REMOVED THE LA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16395351 ↗
• MalfunctionJun 5, 2017Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  THIS WAS A REVISION CASE USING BRAINLAB IPLAN STEREOTAXY 3.0.6 ON A PREVIOUS PATIENT OF DR. (B)(6) WHO HAD THE ORIGINAL ELECTRODES PLACED IN (B)(6) 2016. DR. (B)(6) PRE-PLANNED NEW TRAJECTORIES USING A NEW MRI WHICH HE LOADED INTO THE OLD STEREOTAXY PLAN FROM THE PREVIOUS SURGERY. THE DAY OF THE SURGERY: · A LOCALIZATION SCAN WAS PERFORMED, LOADED INTO THE PLAN AND FUSED WITH THE MRI USER HAD PLANNED HIS TRAJECTORIES ON. USER APPROVED THE FUSION AND CONTINUED TO STEREOTACTIC PLANNING AND ARC SETTINGS ACQUISITION. FIRST ELECTRODE PLACEMENT: - USER PLACED FIRST ELECTRODE ON THE RIGHT SIDE, REMOVED THE OLD ONE, AND THEN PROCEEDED TO WAKE THE PATIENT UP AND DO MICROELECTRODE TESTING WHICH WAS DEEMED SUCCESSFUL. USER STARTED PLACEMENT OF THE LEFT ELECTRODE WHEN HE NOTICED THE HEADFRAME SEEMED LOOSE. UPON INVESTIGATION IT WAS FOUND ONE OF THE SCREWS ON THE FRAME HAD BECOME LOOSE. ONCE THAT ISSUE WAS RESOLVED, DR. (B)(6) AGREED THAT IT WOULD BE BEST TO PERFORM ANOTHER LOCALIZATION SCAN TO VERIFY NOTHING HAD BEEN CHANGED. SCAN TAKEN, IMPORTED, LOCALIZED, FUSED TO THE ORIGINAL MRI AGAIN, AND THEN ACQUIRED THE ARC SETTINGS. NO CHANGE WAS MADE TO THE SETTINGS BY USER. SECOND ELECTRODE PLACEME

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6611017 ↗
• Oct 17, 2016Use of Device Problem; Use of Device Problem

  A MINIMALLY INVASIVE SURGICAL PROCEDURE FOR LASER ABLATION IN THE LEFT HIPPOCAMPUS AREA OF THE BRAIN WAS INTENDED TO BE PERFORMED, THE BRAINLAB IPLAN STEREOTAXY PLANNING SOFTWARE WAS USED TO PLAN THE TRAJECTORY IN A PRE-OPERATIVE MRI DATASET. DURING THE PROCEDURE THE SURGERY TEAM: - ATTACHED THE RADIONICS BRW HEAD FRAME (NON-BRAINLAB, COMPATIBLE TO THE BRAINLAB PLANNING SW) TO THE PATIENT'S HEAD. - OBTAINED A CRANIAL CT IMAGE SET USING THE AIRO SCANNER, AND PUSHED THE IMAGE SET TO THE BRAINLAB IPLAN STEREOTAXY PLANNING SW. - IN THE PLANNING SW, INADVERTENTLY SELECTED A FORMER, 2 WEEKS OLD OTHER CT IMAGE SET FROM A DIFFERENT SURGERY BEFORE OF THE SAME PATIENT WITH THE SAME STEREOTACTIC FRAME IN A DIFFERENT POSITION ON THE PATIENT'S HEAD, AND FUSED THIS CT SET TO THE PRE-OPERATIVE MRI CONTAINING THE INTENDED TRAJECTORY. - RECORDED THE COORDINATES FOR THE SETTINGS OF THE STEREOTACTIC ARC (RADIONICS CRW) FOR THE PLANNED TRAJECTORY FROM THE PLANNING SW (USING THE DIFFERENT, FORMER POSITION OF THE STEREOTACTIC FRAME ON THE HEAD). - ALIGNED THE STEREOTACTIC ARC TO THE CALCULATED COORDINATES, AND CHECKED THE ARC'S TRAJECTORY ON A STEREOTACTIC PHANTOM. - PUT THE STEREOTACTIC ARC ON THE PATI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6033531 ↗