MAUDE Adverse Event Report: BRAINLAB AG NAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.6); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number	22268A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An open surgery on the thoracic spine for a fusion of vertebrae t7-t10, due to a fracture at t10/t11, was intended to be performed with the aid of the display by the brainlab navigation software spine&trauma 3d 2.6.During the procedure the surgeon: - with the patient in prone position, attached the navigation reference array on the spinous process of vertebra t7.- acquired an intra-operative c-arm scan of the patient's region of interest with automatic image registration of the current patient anatomy to the navigation, verified the registration and accepted the accuracy to proceed.- used the navigated pointer to determine the location of the pilot holes, and opened the cortical bone with a not navigated non-brainlab drill at the determined locations.- used a non-brainlab thoracic probe, calibrated to the navigation for instrument position display on the patient scan, to expand/finalize the pilot holes in the vertebrae for the following screws.- placed the spine screws at t7-t10 following the pilot holes with a non-brainlab not navigated screwdriver.- acquired an intra-operative c-arm scan to verify the screw placements and determined that all 8 screws placed with the aid of navigation deviated from their intended position (towards patient's left by ca.7mm and slightly cranially).- decided to remove the deviating spine screws and closed the patient.According to the surgeon (treating clinician): - the deviation of 8 of the 8 pilot holes placed with the aid of navigation was detected by the surgeon with a post-op ct, the surgeon removed all 8 screws and aborted the surgery.A revision surgery was not reported to have been scheduled or taken place.- there was no direct (or increased) risk to harm a critical structure due to the deviating placements.- there was no harm nor negative effect to the patient due to the deviating initial placements, also not due to surgery/anesthesia prolong of ca.30 - 60 minutes.- 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 pilot holes were placed in the patient's spine in a different position than desired with navigation involved, although according to the surgeon (treating clinician): - the deviation of 8 of the 8 pilot holes placed with the aid of navigation was detected by the surgeon with a post-op ct, the surgeon removed all 8 screws and aborted the surgery.A revision surgery was not reported to have been scheduled or taken place.- there was no direct (or increased) risk to harm a critical structure due to the deviating placements.- there was no harm nor negative effect to the patient due to the deviating initial placements, also not due to surgery/anesthesia prolong of ca.30 - 60 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 the spine openings created with aid of navigation bilateral at t7-t10, deviating towards the patient's left side by ca.7mm and also slightly cranially, is a combination of the following factors: - movement of the patient reference array during the procedure due to an insufficient rigid fixation by the user.Movement of the reference array after patient registration to navigation disrupts the coordinate system established during the registration and causes a deviation between the registered pre-placement scan, on which navigated instruments are tracked, and the actual patient anatomy.This movement cannot be compensated by the navigation software.Image data for this surgery provided by the hospital show that the navigation reference array was insufficiently fixated at the base of t7 spinous process and spanning to the t6 spinous process and the interspinal ligament in between, not ensuring a rigid fixation to the patient anatomy and making the array prone to inadvertent movements while applying forces during instrumentation.- relative movements of the spine anatomy during the surgery between the vertebra the navigation reference array was fixated to (t7), and the vertebrae operated on due to an insufficiently rigid connection of the anatomy in between, and the forces applied to the bone during instrumentation.Multi-level navigation - i.E.Operating on a different vertebra than the one the patient reference array for navigation is fixated to or operating across multiple vertebrae without remounting the patient reference and reregistering - especially if the connection in between the vertebrae is not rigid - results in relative movements of the vertebrae (actual anatomy) during the surgery that cannot be compensated by the navigation software displaying instrument positions on the registered pre-placement patient image scan.Patient image datasets provided by the hospital show a visible shift in the patient anatomy between the two datasets.The direction of the movement between the datasets fits the direction of the misplaced pilot holes in this surgery.Apparently, the resulting deviation between the registered pre-placement patient image scan in the navigation display and the actual patient anatomy during the surgery was not recognized by the user with the appropriate and necessary verification of navigation accuracy throughout the surgery and before performing significant invasive surgical actions.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: NAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.6)
• Common Device Name: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; münchen 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: caroline mackenbach ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 19836821
• Report Number: 8043933-2024-00044
• Device Sequence Number: 20552746
• Product Code: OLO
• UDI-Device Identifier: 04056481106591
• UDI-Public: 04056481106591
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183605
• 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): 07/26/2024

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: 22268A
• Device Catalogue Number: 71116A
• Device Lot Number: SW V. 2.6
• 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: 06/27/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2016
• 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