MAUDE Adverse Event Report: BRAINLAB AG SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number	22268-01C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An open surgery on the lumbar spine for a transforaminal lumbar interbody fusion (tlif) of vertebra l3 to a former existing fusion of vertebrae l4 and l5, due to degenerative changes in the segment l3-l5, with intended placement of 2 vertebra screws bilateral for fixation, was performed with the aid of the brainlab spine & trauma 3d navigation 1.5.From an intra-operative c-arm scan, the surgeon determined that of 1 of the 2 spine screws placed, in vertebra left l3, deviated from its intended target point by ca.10mm.The deviating screw was removed and re-placed to its correct position with navigation at the very same surgery.According to the surgeon (treating clinician): the final outcome of the surgery was successful as intended.There was no direct (or increased) risk to harm a critical anatomical structure due to the deviating placement.There was no harm nor negative effect to the patient due to the deviating initial placement, also not due to surgery/anesthesia prolongation of ca.20min.There were further no remedial actions for the patient done, necessary or planned.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 a pilot hole, k-wire and following screw was placed in the patient's spine in a different path and position than desired with brainlab navigation involved, despite according to the surgeon (treating clinician): the deviation of 1 of the 2 spine screws placed was detected by the surgeon before finalizing the surgery with an intra-operative c-arm scan, and the screw was re-placed to its correct position with navigation at the very same surgery.The final outcome of the surgery was successful as intended.There was no direct (or increased) risk to harm a critical anatomical structure due to the deviating placement.There was no harm nor negative effect to the patient due to the deviating initial placement, also not due to surgery/anesthesia prolongation of ca.20min.There were further no remedial actions for the patient done, necessary or planned.Hospitalization was also not prolonged.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 the pilot hole and k-wire placed in vertebra left l3 with the aid of navigation, and of the following spine screw, deviating from its intended target point by ca.10mm cranially, is a combination of the following factors: relative movements of the patient anatomy during the surgery between the location the navigation reference array was fixated to (ligament between l2 and l3), and the vertebra operated on (l3), due to an insufficiently rigid connection of the anatomy in between, and the forces applied to the bone during instrumentation (for e.G.Malleting).This effect occurred in combination with the user inadvertently fixating the navigation reference array at the ligament, instead of as intended and required rigidly on the spinous process of the vertebra operated on (l3).Navigation and imaging data provided for this surgery show a position change of the vertebra l3 in between the pre-placement and post-placement patient image scans.Additionally, the patient had osteoporosis and weak bone quality, reducing the rigidity of the spine further.Movements of the vertebra (actual anatomy) operated on during the surgery, in relation to the reference array location, cannot be compensated for by the navigation software displaying instrument positions on the registered pre-placement patient image scan.A movement of the navigation reference array during the surgery and after registering the pre-placement image scan to the navigation, due to insufficient rigid fixation to the spinous process by the user, not as required, and forces applied to the patient anatomy during instrumentation.Imaging data provided for this surgery show the array inadvertently attached to the ligament instead of the spinous process, and the corresponding movement of the array in between the pre- and post-placement c-arm scans.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 for position visualization, and the actual patient anatomy, which cannot be compensated by the navigation software.Apparently, the resulting deviation between the locations of the actual patient anatomy and the registered pre-placement patient image scan displayed by the navigation, was not recognized by the user for the affected placement with the appropriate and necessary navigation accuracy verification throughout the surgery, especially after forces have 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 3D NAVIGATION SOFTWARE (VERSION 1.5)
• 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: 22087498
• Report Number: 8043933-2025-00042
• Device Sequence Number: 7885946
• Product Code: OLO
• UDI-Device Identifier: 04056481142025
• UDI-Public: 04056481142025
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K212245
• 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
• Report Date (Section B): 05/27/2025

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: 22268-01C
• Device Catalogue Number: 26784
• Device Lot Number: SW V. 1.5.1
• 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: 04/28/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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