MAUDE Adverse Event Report: BRAINLAB AG SPINE & TRAUMA NAVIGATION (VERSION 2.0); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number	22268-04
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since 3 pedicle 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 3 of the 4 pedicle screws placed with the aid of navigation was detected by the surgeon before finalizing the surgery, and the screws were corrected to their intended positions with navigation at the very same surgery.The final outcome of the surgery was successful as intended, with all screw placements correct at the end of the surgery.There was no direct (or increased) risk to harm a critical structure due to the deviating placements.There was neither harm nor negative effect to the patient due to the deviating initial placements, also not due to surgery/anesthesia prolongation of ca.30 minutes.There were further no remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.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 three spine screws placed deviating cranially from their intended positions, by 7 - 10 mm, with the aid of navigation is: movement of the patient reference array during the procedure in relation to the patient anatomy, due to an insufficient rigid fixation by the user, not as required by brainlab, and/or inadvertent forces applied to the array.The patient reference array was attached to the two-pin fixator with fixation pins that were longer than the specified length in the user guide.It was also observed that the patient array was bumped when situating the bovie and suction.The movement was detected and navigation accuracy was checked on the bone (limited by the minimally invasive nature of the case) with the drill guide.Nevertheless, the screw placed prior to the detected movement of the patient reference array was correctly placed, while the screws placed afterwards were incorrectly placed and the deviation of all three screws was in the same direction.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, and the actual patient anatomy.This movement cannot be compensated by the navigation software.Apparently, the resulting deviation between the registered pre/intra-operative image scan in the navigation display and the actual patient anatomy was not recognized by the user with the appropriate and necessary accuracy verification throughout the procedure, before and during performing significant invasive actions with the aid of navigation.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 minimally invasive surgery on the lumbosacral spine for a transforaminal lumbar interbody fusion (tlif), with intended placement of 4 pedicle screws bilateral for fixation (at l5 and s1), was performed with the aid of the display by the brainlab navigation software spine & trauma navigation 2.0.From intra-operative anteroposterior (ap) and lateral x-ray scans, the surgeon discovered that 3 of the 4 pedicle screws placed with the aid of navigation deviated from their intended positions (by 7- 10 mm cranially at right l5 and both sides of s1).According to the surgeon (treating clinician): the deviation of 3 of the 4 pedicle screws placed with the aid of navigation was detected by the surgeon before finalizing the surgery, and the screws were corrected to their intended positions with navigation at the very same surgery.The final outcome of the surgery was successful as intended, with all screw placements correct at the end of the surgery.There was no direct (or increased) risk to harm a critical structure due to the deviating placements.There was neither harm nor negative effect to the patient due to the deviating initial placements, also not due to surgery/anesthesia prolongation of ca.30 minutes.There were further no remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.

• Brand Name: SPINE & TRAUMA NAVIGATION (VERSION 2.0)
• Common Device Name: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: kilonzo ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 21909742
• Report Number: 8043933-2025-00030
• Device Sequence Number: 4009008
• Product Code: OLO
• UDI-Device Identifier: 04056481143954
• UDI-Public: 04056481143954
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

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: 22268-04
• Device Lot Number: SW V. 2.0.0
• 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: 03/27/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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