MAUDE Adverse Event Report: BRAINLAB AG ALIGNMENT SOFTWARE CRANIAL (VERSION 2.0); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC, PRODUCT CODE: HAW

Model Number	22884-02
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A cranial surgery for a biopsy of a ca.6.35 ccm lesion, located in the occipital region of the brain, at ca.38 mm deep, has been performed with the aid of the brainlab alignment software cranial 2.0 (on (b)(6) 2025).After samples were taken, the results were inconclusive.The surgeon decided to change the procedure to an open biopsy, and continued without use of navigation.According to the surgeon (treating clinician): - after the desired sample was not obtained with aid of navigation (results were inconclusive), the surgeon changed to an open biopsy, and completed the surgery without aid of navigation.- the final outcome of the surgery was successful as intended (diagnostic sample was collected).- there was no direct (or increased) risk of harm to a critical structure due to the potentially unintended tissue resections.- there was neither harm nor negative effect to the patient due to the potentially unintended tissue resections nor due to the surgery/anesthesia prolongation of 1h.- there were further no remedial actions necessary, done or planned for this patient due to the potentially unintended tissue resections.There was also no prolongation of hospitalization.
Additional Manufacturer Narrative
B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since tissue was potentially resected in a different location in the brain than anticipated with brainlab alignment software involved, although according to the hospital/surgeon (treating clinician): - after the desired sample was not obtained with aid of navigation (results were inconclusive), the surgeon changed to an open biopsy, and completed the surgery without aid of navigation.- the final outcome of the surgery was successful as intended (diagnostic sample was collected).- there was no direct (or increased) risk of harm to a critical structure due to the potentially unintended tissue resections.- there was neither harm nor negative effect to the patient due to the potentially unintended tissue resections nor due to the surgery/anesthesia prolongation of 1h.- there were further no remedial actions necessary, done or planned for this patient due to the potentially unintended tissue resections.There was also no prolongation of hospitalization.H6: 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.
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 location in the brain than anticipated and planned with the brainlab navigation involved, although according to surgeon (treating clinician): the purpose of this surgery was to receive a diagnostic sample, not to remove the lesion and/or treat the disease.The final outcome of the surgery was successful as intended (diagnostic sample was collected).There was no direct (or increased) risk of harm to a critical structure due to the deviating biopsy path.There was neither harm nor negative effect to the patient due to the deviating biopsy path nor due to the surgery/anesthesia prolongation of 1h.There were further no remedial actions necessary, done or planned for this patient due to the deviating biopsy path.There was also no prolongation of hospitalization.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 the deviating biopsy path (by ca.7mm laterally left) and inconclusive samples collected with aid of navigation is: 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 only.The points were not sufficiently distributed on the required distinctive (bony) surfaces, i.E.On both sides of the patient's face and nose.Points were also acquired in areas prone to skin shift near the lateral canthi of both eyes and on the back of the head, which display indentation near the eyes and skin dragged or shifted anteriorly on the back of the head.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, as seen by the rotation present in registration used for navigation.Apparently, the resulting deviation of the instrument locations displayed by the navigation compared to their positions on and in the actual patient anatomy during the surgery was not recognized by the user with the necessary navigation accuracy verification of the registration and continuously throughout the procedure.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 ca.6.35 ccm lesion, located in the occipital region of the brain, at ca.38 mm deep, has been performed with the aid of the brainlab alignment software cranial 2.0.After samples were taken, the results were inconclusive.The surgeon decided to change the procedure to an open biopsy and continued without use of navigation.According to the surgeon (treating clinician): after the desired sample was not obtained with aid of navigation (results were inconclusive), the surgeon changed to an open biopsy and completed the surgery without aid of navigation.The final outcome of the surgery was successful as intended (diagnostic sample was collected).There was no direct (or increased) risk of harm to a critical structure due to the potentially unintended tissue resections nor due to the revision open biopsy entry.There was neither harm nor negative effect to the patient due to the potentially unintended tissue resections nor due to the surgery/anesthesia prolongation of 1h.There were further no remedial actions necessary, done or planned for this patient due to the potentially unintended tissue resections.There was also no prolongation of hospitalization.

• Brand Name: ALIGNMENT SOFTWARE CRANIAL (VERSION 2.0)
• Common Device Name: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC, PRODUCT CODE: HAW
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: boutaina mediane ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 22412982
• Report Number: 8043933-2025-00048
• Device Sequence Number: 15871462
• Product Code: HAW
• UDI-Device Identifier: 04056481144487
• UDI-Public: 04056481144487
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K223864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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
• Operator of Device: Health Professional
• Device Model Number: 22884-02
• Device Catalogue Number: 22889
• Device Lot Number: SW V. 2.0
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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