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

Model Number	22268-04
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
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 a pilot hole and a k-wire were placed in the patient's spine in a different position than desired with brainlab navigation involved, despite according to the surgeon (treating clinician): - the deviation of 1 of 6 spine k-wires placed with the aid of navigation was detected by the surgeon before finalizing the surgery, and the k-wire was corrected to its intended position with navigation at the very same surgery, before inserting its following spine screw.- the final outcome of the surgery was successful as intended, with all placements correct at the end of the surgery.- there was no harm nor negative effect to the patient resulting, despite there was a direct (or increased) risk to harm a critical structure due to a bone breach to the spinal cord by the deviating placement, and there was also no negative effect due to the surgery/anesthesia prolongation of ca.15min.- there were further no remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.H6: the device evaluation is currently ongoing.Brainlab intends to issue a follow-up report upon completion of the device evaluation.
Event or Problem Description
A minimally invasive surgery on the thoracic and lumbar spine for a percutaneous dorsal stabilization of vertebrae t12 to l2, due to a fracture on l1, with intended placement of 4 vertebra screws bilateral for fixation, and 2 vertebra stents to apply bone filling, was performed with the aid of the brainlab spine & trauma navigation 2.0.From an intra-operative ct scan, the surgeon determined that of 1 of the 6 spine k-wires placed with the aid of navigation, in vertebra left t12, deviated shifted medial by ca.5mm from its intended position.The deviating k-wire was removed and re-placed to its intended position with navigation at the very same surgery, before inserting its following spine screw.According to the surgeon (treating clinician): - the final outcome of the surgery was successful as intended, with all placements correct at the end of the surgery.- there was no harm nor negative effect to the patient resulting, despite there was a direct (or increased) risk to harm a critical structure due to a bone breach to the spinal cord by the deviating placement, and there was also no negative effect due to the surgery/anesthesia prolongation of ca.15min.- there were further no 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 a pilot hole and a k-wire were placed in the patient's spine in a different position than desired with brainlab navigation involved, despite according to the surgeon (treating clinician): - the deviation of 1 of 6 spine k-wires placed with the aid of navigation was detected by the surgeon before finalizing the surgery, and the k-wire was corrected to its intended position with navigation at the very same surgery, before inserting its following spine screw.- the final outcome of the surgery was successful as intended, with all placements correct at the end of the surgery.- there was no harm nor negative effect to the patient resulting, despite there was a direct (or increased) risk to harm a critical structure due to a bone breach to the spinal cord by the deviating placement, and there was also no negative effect due to the surgery/anesthesia prolongation of ca.15min.- 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 the pilot hole and k-wire placed in vertebra left t12 with the aid of navigation, deviating shifted medial by ca.5mm from its intended position, is: - temporary movement of the navigation reference array during the instrumentation of left t12, due to an insufficiently rigid fixation to the bone by the user, and forces applied to it during this instrumentation, for e.G.Transferred by the skin surrounding the array for this minimally invasive approach, and/or the spine.The array was inadvertently hit by the user before, and while this was immediately recognized and addressed by the user with an update of the anatomy registration to navigation with the intra-operative ct scanner, navigation and imaging data provided for this surgery show that the array clamp fixation on the spinous process also had moved, indicating that the array fixation to the bone was no longer sufficiently stable in general, making the reference array prone to movements by any forces applied to the patient during the surgery.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 no longer sufficiently rigid connection of the reference array to the bone had not been detected by the user with their check of the array fixation after the bumping, and the resulting deviation of the anatomy location displayed by the navigation was not recognized by the user with the required thorough verification of the navigation accuracy throughout the surgery, before and during the affected significant invasive actions, and after significant forces had been 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.
Event or Problem Description
A minimally invasive surgery on the thoracic and lumbar spine for a percutaneous dorsal stabilization of vertebrae t12 to l2, due to a fracture on l1, with intended placement of 4 vertebra screws bilateral for fixation, and 2 vertebra stents to apply bone filling, was performed with the aid of the brainlab spine & trauma navigation 2.0.From an intra-operative ct scan, the surgeon determined that of 1 of the 6 spine k-wires placed with the aid of navigation, in vertebra left t12, deviated shifted medial by ca.5mm from its intended position.The deviating k-wire was removed and re-placed to its intended position with navigation at the very same surgery, before inserting its following spine screw.According to the surgeon (treating clinician): - the final outcome of the surgery was successful as intended, with all placements correct at the end of the surgery.- there was no harm nor negative effect to the patient resulting, despite there was a direct (or increased) risk to harm a critical structure due to a bone breach to the spinal cord by the deviating placement, and there was also no negative effect due to the surgery/anesthesia prolongation of ca.15min.- there were further no remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.

• Brand Name: SPINE & TRAUMA NAVIGATION 2.0
• 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: 22077138
• Report Number: 8043933-2025-00041
• Device Sequence Number: 15839756
• Product Code: OLO
• UDI-Device Identifier: 04056481143954
• UDI-Public: 04056481143954
• 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): 06/10/2025

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 Catalogue Number: 22268F
• Device Lot Number: SW V. 2.0.1
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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