MAUDE Adverse Event Report: BRAINLAB SE ALIGNMENT SOFTWARE CRANIAL; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	22884-02
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since a biopsy of brain tissue was performed in a different position than desired with brainlab navigation involved.At the current point in time, - there was neither a harm or negative effect to the patient reported due to the deviating biopsy path and location, nor a surgery/anesthesia prolongation or changes to the planned surgery procedure.- there were further no remedial actions reported necessary, done or planned for this patient as well as no prolongation of hospitalization.Further details of the effects on the patient could not yet be retrieved from the hospital.Brainlab continues to follow up with the hospital.A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report upon completion of the investigation.H6, h7: a comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report upon completion of the investigation.
Event or Problem Description
A cranial surgery for a biopsy of brain tissue was performed with the aid of brainlab alignment software cranial 2.0.From a post operative scan, the surgeon determined that the biopsy deviated from its intended position/ trajectory.At the current point in time, - there was neither a harm or negative effect to the patient reported due to the deviating biopsy path and location, nor a surgery/anesthesia prolongation or changes to the planned surgery procedure.- there were further no remedial actions reported necessary, done or planned for this patient as well as no prolongation of hospitalization.Further details of the effects on the patient could not yet be retrieved from the hospital.Brainlab continues to follow up with the hospital.
Additional Manufacturer Narrative
B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since a biopsy was performed in a different path and location in the brain than anticipated and planned with the brainlab navigation involved, despite according to the surgeon (treating clinician): - the purpose of this surgery was to receive a diagnostic sample, not to remove or treat the lesion.- the desired pathological/diagnostic tissue was retrieved with navigation at the very same surgery.- there was no harm or negative effect to the patient resulting due to the deviating biopsy path and location, and there was no surgery/anesthesia prolongation since there were no changes to the planned surgery procedure done.- there were further no remedial actions necessary, done or planned for this patient.There was also no prolongation of hospitalization.There is no indication of a systematic error or malfunction of the brainlab device (navigation).Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place.H6: according to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause of a biopsy planned and performed with aid of navigation that deviated from planned trajectory by ca.15 - 20 mm at entry and target is: - a movement of the navigation reference array or head during the surgery due to inadvertent forces applied on it, after the patient registration to navigation and before draping.The entry point of the trajectory that was marked on the head was created after registration and checked after draping.Once the patient was draped, the surgeon noted the marked entry was no longer in line with the trajectory.According to the information in the questionnaire, the deviated entry was discovered but not corrected by updating the trajectory in the software.A relative shift between the reference array and the patient's head, or vice versa, explains the shifted entry point discovered during the accuracy verification after draping and the subsequent deviation of the actual biopsy path from the intended trajectory.Movement of the reference array after patient registration to navigation disrupts the coordinate system established during the registration and causes a deviation between the displayed image scan, on which the navigated instruments are tracked, and the actual patient anatomy.This movement cannot be compensated for by the navigation software.Further contributing factor is: - incorrect inner guide disc diameter used for biopsy needle navigation through varioguide.Per information provided by brainlab support, the diameter of the guide disc for the varioguide was set to larger than the recommended 1.8 - 2.1 mm.This allows extra space around the biopsy needle inside the varioguide which can alter the angle or position of the biopsy needle to the intended trajectory.- an insufficient distribution of surface registration points acquired by the user for the patient anatomy registration to navigation, not following brainlab requirements.The provided data from this surgery shows that registration points were acquired with the softouch on rounded, unspecific areas such as the forehead and side of head.The points were also not sufficiently distributed on the required distinctive (bony) surfaces, i.E.On both sides of the patient's nose, on back of head, side of head, and region of interest.This caused the navigation software to not find an as accurate as desired match, for this specific procedure, between the pre-operative image dataset and the actual patient anatomy, in the region of interest.Apparently, the resulting deviation of the anatomy location displayed by the navigation was recognized by the user after draping the patient, however the user chose to proceed.The resulting deviation from the trajectory was not recognized during the procedure with the required thorough verification of the navigation accuracy throughout the surgery, for e.G.After forces have been applied, and before applying significant invasive surgical actions.There is no indication of a systematic error or malfunction of the brainlab device (navigation).Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place.H7: brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.
Event or Problem Description
A cranial surgery for a biopsy of a lesion, located right parietal ca.53mm deep in the brain, has been performed with the aid of the brainlab alignment software cranial 2.0.From a post-operative mri scan the surgeon determined that the biopsy path and location had deviated from the planned trajectory shifted by ca.15-20 mm at target and entry, with the samples taken at the edge of the lesion mass.According to the surgeon (treating clinician): - the purpose of this surgery was to receive a diagnostic sample, not to remove or treat the lesion.- the desired pathological/diagnostic tissue was retrieved with navigation at the very same surgery.- there was no harm or negative effect to the patient resulting due to the deviating biopsy path and location, and there was no surgery/anesthesia prolongation since there were no changes to the planned surgery procedure done.- there were further no remedial actions necessary, done or planned for this patient.There was also no prolongation of hospitalization.

• Brand Name: ALIGNMENT SOFTWARE CRANIAL
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BRAINLAB SE; olof-palme-strasse 9; munich, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB SE; olof-palme-strasse 9; munich, 81829 ; GM 81829
• Manufacturer Contact: nina duerr ; olof-palme-strasse 9; munich, 81829 ; GM 81829
• MDR Report Key: 23604520
• Report Number: 8043933-2025-00085
• Device Sequence Number: 13039584
• Product Code: HAW
• UDI-Device Identifier: 04056481144487
• UDI-Public: 04056481144487
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K223864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 22884-02
• Device Catalogue Number: 22890
• Device Lot Number: SW V. 2.0.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown