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 Problems Cerebrospinal Fluid Leakage (1772); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2022

Event Type  Injury  

Event Description

A minimally invasive, later changed to open, surgery on the lumbar spine for stabilization and fixation due to a fracture of vertebra l3, with intended placement of 4 spine screws bilateral in vertebrae l2 and l4, was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 1.5.During the procedure the surgeons: with the patient in prone position, attached the navigation reference array on the spinous process of vertebra l4.Acquired an intra-operative c-arm scan 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 for first orientation for the screw placements, calibrated.A non-brainlab screwdriver to navigation for instrument position display, and with it placed shorth k-wires for cortical bone opening and the screws bilateral in l4 and l2.After placement of the last spine screw in right l2, at removal of the navigated non-brainlab screwdriver, observed a change in the instrument position display of the navigation, suspected this screw to deviate from the intended position and removed it immediately.Performed an intra-operative c-arm verification scan, which showed that the right l2 screw had deviated ca.10mm medial from its intended position, and into the spinal channel.The deviating screw in right l2 had caused a dura tear (csf leak), that required a dura repair by suturing at this very same surgery.The surgery had to be converted to an open surgery, after immediate removal of the right l2 screw, to address the dura tear with a (originally not planned) laminectomy to access the tear for suturing.The deviating l2 screw was re-placed to its correct position freehand, without using navigation, in the now open access to the vertebra.According to the surgeons: the deviation of 1 of the 4 spine screws placed with the aid of navigation, was detected during the same surgery immediately after its placement, and confirmed with an intra-operative verification scan.This placement was corrected freehand at the very same surgery after it had been converted to an open surgery.The final outcome of the surgery in regard to the intended spine fixation was successful as intended, with all placements correct at the end of the surgery.The dura tear caused by the misplaced screw was addressed at the same surgery by immediately removing the screw, converting the surgery to an open surgery with laminectomy for access, and suturing the tear.There was no other harm or negative effect to the patient currently, there is no neurological deficit for the patient, and there are currently no further remedial actions for the patient done, necessary or planned, except for a follow-up on the patient at a later point of time.There was also no negative effect to the patient due to the surgery/anesthesia prolong of ca.45-60min.Hospitalization was not prolonged either.

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a screw was placed in the patient's spine in a different position than desired with navigation involved, and into the spinal channel causing a dura tear, although according to the surgeons: the deviation of 1 of the 4 spine screws placed with the aid of navigation, was detected during the same surgery immediately after its placement, and confirmed with an intra-operative verification scan.This placement was corrected freehand at the very same surgery after it had been converted to an open surgery.The final outcome of the surgery in regard to the intended spine fixation was successful as intended, with all placements correct at the end of the surgery.The dura tear caused by the misplaced screw was addressed at the same surgery by immediately removing the screw, converting the surgery to an open surgery with laminectomy for access, and suturing the tear.There was no other harm or negative effect to the patient currently, there is no neurological deficit for the patient, and there are currently no further remedial actions for the patient done, necessary or planned, except for a follow-up on the patient at a later point of time.There was also no negative effect to the patient due to the surgery/anesthesia prolong of ca.45-60min.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 screw at right l2 deviating by ca.10mm medial and into the spinal channel is: a relative movement of the vertebra l2 during the surgery in relation to the vertebra l4 the navigation reference array was attached to, due to the forces applied to the bone during the screw placement.The vertebra movement was caused by applying force to the bone using the screwdriver, so that the k-wire opening the cortical bone, and the screw can be entered into the bone.As per the surgeons, a movement of the screwdriver position display was observed in the navigation on the registered pre-placement scan at removal (release of forces) of the screwdriver.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, which displays instrument positions on the registered pre-placement patient image scan.Apparently, the resulting deviation between the actual patient anatomy during surgery and the registered pre-placement patient image scan displayed by the navigation, was not recognized by the user with the appropriate and necessary navigation accuracy verification throughout the surgery, during preparation and placement of the screw at right l2.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.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)
• 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: 14755461
• MDR Text Key: 294934867
• Report Number: 8043933-2022-00036
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 04056481142025
• UDI-Public: 04056481142025
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K212245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/30/2022

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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• 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; Required Intervention