MAUDE Adverse Event Report: Brainlab SE Spine & Trauma Navigation 3.0.; Image Guided Surgery System/Instrument, Stereotaxic

Model Number	22268-04C
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An open surgery on the thoracic and lumbosacral spine, for a fusion of vertebrae t8 to s2, with intended placement of 24 screws bilateral for fixation, was performed with the aid of the display by the brainlab navigation software spine & trauma navigation 3.0.From a post-operative ct scan the surgeon discovered that 2 of the 24 screws, placed with the aid of navigation, deviated from their intended positions (at t9 and the ilium, both on the patient's right side).According to the surgeon (treating clinician): - the deviation of 2 of the 24 screws placed with the aid of navigation was detected by the surgeon with a post-operative ct.A revision surgery was scheduled and took place five days after the initial surgery.- the outcome of the revision surgery was successful, with the deviating screw placements corrected to their intended positions.- there was no actual harm/negative clinical effect to the patient due to the deviating placements.- the duration of the original surgery/anesthesia was not prolonged due to this issue (the deviations were detected only afterwards).There was no negative clinical effect on the patient due to anesthesia duration of ca.1.25 h for the revision surgery performed five days later.- there were no further remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.
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 surgeon (treating clinician): - the deviation of 2 of the 24 screws placed with the aid of navigation was detected by the surgeon with a post-operative ct.A revision surgery was scheduled and took place five days after the initial surgery.The outcome of the revision surgery was successful, with the deviating screw placements corrected to their intended positions.There was no actual harm/negative clinical effect to the patient due to the deviating placements.The duration of the original surgery/anesthesia was not prolonged due to this issue (the deviations were detected only afterwards).There was no negative clinical effect on the patient due to anesthesia duration of ca.1.25 h for the revision surgery performed five days later.There were no further remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.A comprehensive investigation by branlab 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 to the fda upon completion of investigation.

• 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: 50079721
• Report Number: 8043933-2026-00054
• Device Sequence Number: 21522595
• Product Code: OLO
• UDI-Device Identifier: 04056481144906
• UDI-Public: 04056481144906
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K221618
• 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): 08/19/2026

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: 22268-04C
• Device Catalogue Number: 22268G
• Device Lot Number: SW v.3.0
• 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: 06/30/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown