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

Model Number 22268-01C

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since screws were placed in the patient's spine in a different position than desired with navigation involved, although according to the hospital (fellow surgeon/clinician): the deviation of 3 of the 12 spine screws placed with the aid of navigation was detected by the surgeon with intra-operative ct scans before finalizing the surgery, and these placements were addressed with navigation at the very same surgery.The final outcome of this surgery was successful as intended, with the placements correct at the end of the surgery.There was no direct (or increased) risk to harm a critical structure by the deviating placements.There was no harm nor negative effect to the patient due to the deviating initial placements, and there was no surgery/anesthesia delay for the patient.There were further no remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the deviated screws at right c6 and c5 and left c3 by approx.3-5mm, is: insufficient and inaccurate instrument calibrations of the non-brainlab tap and screwdriver to the navigation by the user.These inaccurate calibrations were caused by multiple use factors.For both instruments, the software displayed warning messages of the low accuracy calibration results.The user performed navigation accuracy checks with the instruments and accepted the warnings and the calibrations to use the instruments with navigation.Further, the non-brainlab tap and screwdriver have custom-made adapters for the navigation reference array, which have not been validated by brainlab and therefore brainlab is not in a position to determine the accuracy, compatibility, or safety of these non-brainlab instruments, neither in regard to use with brainlab navigation.As an additional factor possibly contributing to the deviated placements to a lesser extent, are: relative movements between the vertebrae operated on and the vertebra / head holder where the navigation reference array was placed (fixated on t2 for c6 placements, and later on the head holder for c3 and c5 placements), due to the forces applied to the bone during the surgery.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 -can result 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.An anatomical movement is visible in between the intra-operative ct scans at this surgery.Apparently, the resulting deviation between the actual patient anatomy during surgery and the registered preplacement patient image scan displayed by the navigation was not recognized by the user with the necessary navigation accuracy verification throughout the procedure, during the preparation and placement of the screws.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.

Event Description

A minimally invasive surgery on the spine for a posterior cervicothoracic fusion (pcf) of vertebrae c3 to t2, for a hyperkyphosis of the cervical spine, with intended placement of 12 vertebra screws for fixation, was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 1.5.During the procedure the surgeon: fixated the patient's head in a non-brainlab head holder, and with the patient in prone position, attached the navigation reference array on the spinous process of vertebra t2.Acquired an intra-operative ct scan of the lower half of 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.Starting with left t2, used the navigated pointer to determine the screw trajectory for the stab incisions and the navigated drill guide 3.2mm to drill into the vertebrae to create the pilot holes.Calibrated a non-brainlab tap to navigation, and after the navigation displayed a low accuracy warning of the instrument calibration, performed a navigation accuracy check with the instrument, accepted the warning and the calibration to thread the pilot holes.To place the spine screws, also calibrated a non-brainlab screwdriver to navigation, the navigation displayed a low calibration accuracy warning also for this instrument, with the warning and instrument calibration accepted by the user after a navigation accuracy check.Placed the screws with the screwdriver under navigation following and into the threaded pilot holes in vertebrae t2-c6.For the upper half of this procedure, fixated a different navigation reference array to the head holder, and acquired another intra-operative ct scan of the upper half of patient's region of interest with automatic image registration to navigation.With the same navigated method as before, and with the same calibrated instruments, prepared and placed the screws in vertebrae c5 to c3.Acquired verification intra-op ct scans with automatic registration, and determined that the left c3 screw, as well as the right c5 and right c6 screws deviated from their intended positions by ca.3-5mm.Decided to remove these 3 vertebra screws, performed a new instrument calibration to navigation, and re-placed the left c3 screw, as well as placing an additional screw in right c4 with navigation (with the right c5 and c6 screws remaining removed).Confirmed with a final verification intra-op ct scan that all placements were correct.Completed the fusion surgery successfully as intended and closed the patient.According to the hospital (fellow surgeon/clinician): the deviation of 3 of the 12 spine screws placed with the aid of navigation was detected by the surgeon with intra-operative ct scans before finalizing the surgery, and these placements were addressed with navigation at the very same surgery.The final outcome of this surgery was successful as intended, with the placements correct at the end of the surgery.There was no direct (or increased) risk to harm a critical structure by the deviating placements.There was no harm nor negative effect to the patient due to the deviating initial placements, and there was no surgery/anesthesia delay for the patient.There were further no remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.

• Brand Name: SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5)
• Type of Device: 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: 15586923
• MDR Text Key: 301562167
• Report Number: 8043933-2022-00057
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 04056481142025
• UDI-Public: 04056481142025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22268-01C
• Device Catalogue Number: 26509D
• Device Lot Number: SW V. 1.5.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other