MAUDE Adverse Event Report: BRAINLAB SE SPINE &TRAUMA NAVIGATION 3.0; IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number	22268-01G
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An open surgery on the sacro-lumbar spine for a fusion extension of vertebrae l2 to l3 and s1 to s2 (previous fusion at l4-l5), with laminectomy/decompression and intended placement of 8 spine screws bilateral for fixation (at l2, l3, s1, and s2), was performed with the aid of the display by the brainlab navigation software spine & trauma navigation 3.0.From an intra-operative x-ray scan, the surgeon discovered that two of the eight screws (at right l2 & left l3) placed with the aid of navigation deviated from their intended positions into the canal.According to the limited information from the hospital/surgeon (during surgery): the deviation of the screws placed in the patient's spine with the aid of navigation was detected by the surgeon before finalizing the surgery, and the screws were corrected to their intended positions at the very same surgery.There was no harm nor negative clinical effect to the patient was reported neither due to the deviating placements, nor due to surgery/anesthesia prolongation of ca.60 minutes.No further remedial actions for the patient were reported that would have been done, necessary or planned, nor was prolongation of hospitalization reported.
Additional Manufacturer Narrative
B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since two screws were placed in the patient's spine in different positions than desired with brainlab navigation involved, although according to the limited information from the hospital/surgeon (during the case): the deviation of the screws placed in the patient's spine with the aid of navigation was detected by the surgeon before finalizing the surgery, and the screws were corrected to their intended positions at the very same surgery.All screw placements were correct at the end of the surgery.There was no harm nor negative clinical effect to the patient was reported neither due to the deviating placements, nor due to surgery/anesthesia prolongation of ca.60 minutes.No further remedial actions for the patient were reported that would have been done, necessary or planned, nor was prolongation of hospitalization reported.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 support, it can be concluded that the main root cause for the initial deviating spine pedicle screw placements performed with the aid of navigation, is: an inaccurate registration due to suboptimal point acquisition and an insufficient distribution of surface registration points, not following brainlab requirements.In this case, log file values indicate an imprecise and poorly distributed acquisition of the initial 3 preplanned points.Additionally, the accuracy values associated with the software acquired matches are similar indicating that the navigation software was unable to accurately match the pre operative image dataset and the patient's actual anatomy in the region of interest due to said suboptimal point collection.Moreover, during navigation, the pointer/drill guide were displayed above the bone, which is consistent with the presence of an inaccurate registration and supports the identified root cause.Apparently, the resulting deviation between the locations of the actual patient anatomy and the registered pre-placement patient image scan displayed by the navigation during the surgery was not recognized by the surgeon with the appropriate and necessary navigation accuracy verification throughout the surgery, and any time significant force was applied to the bone.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: SPINE &TRAUMA NAVIGATION 3.0
• Common Device Name: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB SE; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB SE; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: boutaina mediane ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 24389817
• Report Number: 8043933-2026-00010
• Device Sequence Number: 13334436
• Product Code: OLO
• UDI-Device Identifier: 04056481144906
• UDI-Public: 04056481144906
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K221618
• 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
• Report Date (Section B): 02/19/2026

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: 22268-01G
• Device Catalogue Number: 26663D
• 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: 01/20/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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