MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION 4.1; IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number	26615-03
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A cranial surgery for removal of an abscess, located right temporal ca.5cm deep in the brain, and with a size of ca.0.9ccm, has been performed with the aid of the brainlab cranial navigation 4.1.When after path dissection at the first removal attempt the navigation showed to be in the abscess, but the surgeon was unable to see the abscess within the brain, and neither could locate it with independent non-brainlab ultrasound, the surgeon decided to acquire a ct scan intra-operatively.From the scan the surgeon determined that the abscess had been missed by ca.1-1.5cm mainly in the cranial direction and a little posterior.The surgeon decided to extend the craniotomy (bone flap), and removed the abscess successfully as intended using navigation in combination with independent ultrasound.According to the surgeon (treating clinician): - the final outcome of the surgery was successful as intended, although more tissue was resected than originally planned.- there was no harm or negative effect to the patient, also not due to the surgery/anesthesia prolongation of ca.1h.- there were further no remedial actions necessary, done or planned for this patient.Hospitalization was also not prolonged.
Additional Manufacturer Narrative
B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since dissections/resections were 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 deviation of the path in the brain was detected by the surgeon during the surgery, the abscess was removed successfully at the very same surgery with an intra-operative ct scan, an extension of the craniotomy (bone flap) and using navigation in combination with independent ultrasound.- the final outcome of the surgery was successful as intended, although more tissue was resected than originally planned.- there was no harm or negative effect to the patient, also not due to the surgery/anesthesia prolongation of ca.1h.- there were further no remedial actions necessary, done or planned for this patient.Hospitalization was also not prolonged.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 initial dissection/resection path and location in the brain, performed with the aid of navigation, missing the targeted abscess by ca.1-1.5cm in mainly the cranial direction, is: - a not adequate distribution of surface registration points acquired by the user for the patient anatomy registration to the navigation / to the pre-operative mri scan, not following brainlab requirements.The navigation data from this surgery shows that that the registration points were not sufficiently distributed on the required distinctive (bony) surfaces, i.E.Not sufficiently on both sides of the patient's face (especially not sufficiently on the left side), and also not on the back of the head.The points were collected mainly only on rounded, unspecific areas such as the forehead, and in areas prone to skin shift where the skin surface was altered due to appliances (noise protection) to the patient during the mri scan - all of these should be avoided.Additionally, at least one point was acquired in an area that was not anymore included in the mri scan, which is also to be avoided.This caused the navigation software to not find an as accurate match, between the pre-operative image dataset and the actual patient anatomy in the region of interest, as desired for this procedure.The navigation data provided show a corresponding deviation of the collected pre-registration points versus the planned points after this anatomy registration to navigation.Apparently, the extent of the resulting deviation between the actual patient anatomy location during the surgery and the registered pre-operative patient image scan displayed by the navigation for instrument position visualization was not recognized by the user with the required thorough navigation accuracy verification of the registration, nor with the necessary continued verification of navigation accuracy throughout the procedure, for e.G.After draping of the patient.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.

• Brand Name: CRANIAL NAVIGATION 4.1
• Common Device Name: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• 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: markus hofmann ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 22963368
• Report Number: 8043933-2025-00063
• Device Sequence Number: 12826919
• Product Code: HAW
• UDI-Device Identifier: 04056481143848
• UDI-Public: 04056481143848
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K223288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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: 26615-03
• Device Catalogue Number: 26674B
• Device Lot Number: SW V. 4.1.0
• 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: 08/07/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown