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

Model Number 22268-01B

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 09/19/2022

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since k-wires and a pedicle screw were placed in the patient's spine in a different position than desired with navigation involved, although according to the surgeon: the deviation of the k-wires were determined via intraoperative imaging and replaced during the very same surgery.No information was given regarding when the suboptimal placement of the screw was detected, but this screw was not replaced during the surgery.The outcome of the surgery was considered not successful, since one screw was ultimately placed in a suboptimal position.However, no revision surgery was deemed necessary at this time.Other than the potential (unrealized to date) risk of loosening of the suboptimal placed screw, there was no actual harm/negative clinical effect to the patient due to the surgery, neither due to the prolonged anesthesia of approximately 2 hours.There were no further medical/surgical remedial actions necessary, done, or planned for this patient.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 two different root causes depending on the procedure steps were found.1.Misplacement of the left l5 k-wire by approx.9mm cranially, that was caused by a rotation of the patient reference array (with respect to the clamp) due to an insufficient rigid fixation (as detected by the user) and/or inadvertent forces indirectly applied during the surgery (e.G.During instrumentation) to the reference array after the registration of the patient scan to navigation was performed.Movement of the reference array disrupts the coordinate system established during patient registration and causes a deviation between the registered pre-placement image scan on which navigated instruments are tracked, and the actual patient anatomy.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 surgeon with the appropriate and necessary navigation accuracy verification throughout the surgery, during placement of the affected k-wire.2.Misplacement of the right l4 k-wire by approx.4mm laterally and 4mm cranially and the right l4 screw by approx.7mm laterally, that was caused by relative movements between the vertebra operated on (i.E.L4) and the vertebra where the navigation reference clamp was placed (fixed on l3), 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 clamp for navigation is fixed upon 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 was visible in between the intra-operative ct scans at this surgery.Furthermore, the anatomy of this very vertebra of the patient made it difficult to enter the instruments to the intended trajectory requiring more force and therefore turning relative movements likely.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 surgeon with the appropriate and necessary navigation accuracy verification throughout the surgery, during screw preparation and placement of the affected k-wire / screw.The verification should have been performed at the region of interest and not only on the vertebra l3 where the reference was attached to, as relative movements cannot be detected.The correction of the right l4 k-wire was not verified (at least to the knowledge of brainlab) and it could have happened that the k-wire followed the initial wrong path that the screw then in the end followed as well.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 reiterate the relevant topics regarding the use of the device to this customer.

Event Description

A minimally invasive surgery on the lumbar spine for fusion at vertebrae l4 and l5 to treat spondylolisthesis, with intended placement of 4 pedicle screws for fixation, was performed with the aid of the display by the brainlab spine & trauma 3d navigation software 1.5.During the procedure the surgeon: with the patient in prone position, made a small incision and attached the navigation reference clamp on the spinous process of l3, and attached the navigation reference array to the clamp.Acquired a 3d fluoroscopy scan using an intra-operative scanner with automatic image registration of the current patient anatomy to the navigation, and verified and accepted the accuracy of the registration to proceed.Calibrated the brainlab pedicle access needle (pan) and a non-brainlab screwdriver to the navigation, and verified and accepted the accuracy of the instruments to proceed.Created a path in the right pedicle of l5 using the navigated pan, and placed a k-wire down the path.Noticed the reference movement warning message pop-up display in the navigation software but verified the accuracy of navigation and deemed it acceptable to proceed.Created a path in the left pedicle of l5 using the navigated pan, and placed a k-wire down the path, but determined that the k-wire did not feel like it was in the bone, and its placement did not correspond to the display of the pan in the navigation software.Acquired a confirmation fluoroscopic image, and determined the left l5 k-wire was misplaced approx.9mm cranially into the space between the vertebrae.Noticed the patient reference array was loose at its attachment to the clamp, and tightened it.Acquired another 3d fluoroscopy scan using an intra-operative scanner with automatic image registration of the current patient anatomy to the navigation, and verified and accepted the accuracy of the registration to proceed.Replaced (repositioned) the left l5 k-wire using the navigated pan to create the path in the pedicle, and placed k-wires at the left and right pedicles of l4 in the same manner.Attempted to place a pedicle screw over the right l5 k-wire with the navigated screwdriver, but felt that the tactile feedback of the screw did not correspond to the display of the position of the screw in the navigation software, and did not place the screw.Acquired another 3d fluoroscopy scan using an intra-operative scanner with automatic image registration of the current patient anatomy to the navigation, and verified and accepted the accuracy of the new registration to proceed.Determined via this scan that the k-wire at right l4 was misplaced approximately 4mm cranially and laterally.Replaced (repositioned) the right l4 k-wire using the navigated pan.Placed all 4 screws (at the left and right pedicles of l4 and l5) over the k-wires using the navigated screwdriver.The surgeon noted during the screw placements that the display of the screwdriver in the navigation software did not match its actual position on the patient anatomy during screw placement, but continued to use it with navigation for placing screws over the k-wires.Obtained a final confirmation 3d fluoroscopy scan to check the final screw positions.Completed the surgery.At some point, the surgeon determined the right l4 screw was misplaced laterally (by approx.7mm).Information was not provided by the hospital if the screw misplacement was detected on the final confirmation scan during the surgery, or if it was detected after the surgery was completed.The screw was not replaced.According to the surgeon: the deviation of the k-wires were determined via intraoperative imaging and replaced during the very same surgery.No information was given regarding when the suboptimal placement of the screw was detected, but this screw was not replaced during the surgery.The outcome of the surgery was considered not successful, since one screw was ultimately placed in a suboptimal position.However, no revision surgery was deemed necessary at this time.Other than the potential (unrealized to date) risk of loosening of the suboptimal placed screw, there was no actual harm/negative clinical effect to the patient due to the surgery, neither due to the prolonged anesthesia of approximately 2 hours.There were no further medical/surgical remedial actions necessary, done, or planned for this patient.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: maura pascarella ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 15632391
• MDR Text Key: 302006590
• Report Number: 8043933-2022-00059
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 04056481142025
• UDI-Public: 04056481142025
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22268-01B
• Device Catalogue Number: 22268-01B
• Device Lot Number: SW V. 1.5.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• 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