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

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

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since pedicle screws were placed in the patient's spine in a different position than desired with the brainlab device involved, despite according to the surgeon: the misplaced screw was detected with a fluoroscopic control scan during the surgery, and the screw was replaced (repositioned) successfully to the intended position during the very same surgery.The outcome of the surgery was successful as intended; all screws were placed correctly in their final positions as intended.There was no direct or increased risk of harm to a critical structure (e.G.Spinal cord, nerves, blood vessels, etc.) due to the misplaced screws.There was no harm or negative clinical effect to the patient due to the incorrect screw placement, neither for the negligible prolongation of anesthesia.There were no further medical or surgical remedial actions necessary, done or planned for this patient.Hospitalization was not prolonged.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 deviated left l2 screw placement by approximately 2 - 3 mm lateral at the target point was most likely due to one or more of the following factors: a movement of the patient reference array due to an insufficiently rigid fixation and/or inadvertent forces applied after patient registration was performed.Several reference array movements were detected by the software which issued potential inaccuracy warnings to the user that were ignored (prior to the reference array movement that was observed by personnel attending the case).Movement of the reference array disrupts the coordinate system established during patient registration and causes a deviation between the registered preoperative image on which navigated instruments are tracked and the actual patient anatomy.Relative movement of the anatomy between the l2 vertebra and s1, on which the navigation patient reference was attached.Operating on a different vertebra than the vertebra on which the patient reference array is fixed, or operating over multiple vertebrae without repositioning the reference array and reregistering the patient, especially over a spine instability - such as spondylolisthesis in this patient - can cause anatomical movements between vertebrae that cannot be recognized or compensated by the navigation software.Apparently, the resulting deviation of the registered patient image in the navigation display from the actual patient anatomy was not recognized by the surgeon with the appropriate and necessary accuracy verification during screw preparation and placement at left l2 or when presented with potential inaccuracy warning notices in the navigation display.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

An open surgery on the lumbar spine for an l2-l5 fusion for a deformity/spondylolisthesis with planned placement of 8 pedicle screws, was performed with the aid of the brainlab software spine & trauma 3d navigation 1.5.During the procedure the surgeon: positioned the patient in prone position on the or table and exposed the region of interest.Attached the navigation reference array at s1.Performed an intraoperative 3d fluoroscopic scan and verified and accepted the automatic registration of the current patient anatomy to the navigation (to the intraoperative 3d fluoroscopic scan imported into and used by the navigation).Calibrated a non-brainlab tap and screwdriver to the navigation and verified and accepted the calibration to proceed.Used the navigated brainlab drill guide to align a non-brainlab drill to the right pedicle of l2, and drilled a path in the pedicle.Used a non-navigated non-brainlab probe in the right pedicle at l2, used the navigated tap to prepare the path for the screw, and used the navigated screwdriver to place the screw in the right pedicle of l2.Repeated this surgical workflow using the drill, probe, tap, and screwdriver to place a screw in the left pedicle of l2.Accidentally jostled the patient reference array with an instrument while planning for the next screw.This was observed by other personnel in the room who then prompted the surgeon to re-verify the accuracy of navigation.The navigation software also displayed a movement warning dialog to the user.Verified the accuracy of navigation and observed a lateral deviation of approximately 3-5mm between the display of navigation and the actual position of the patient anatomy.Determined via fluoroscopy that the screw at left l2 was placed approximately 2-3mm lateral from its intended target position, although the screw entry point was correct.Replaced (repositioned) the left l2 screw and placed the remaining 6 screws conventionally without the aid of navigation.Completed the surgery successfully as intended.According to the surgeon: the misplaced screw was detected with a fluoroscopic control scan during the surgery, and the screw was replaced (repositioned) successfully to the intended position during the very same surgery.The outcome of the surgery was successful as intended; all screws were placed correctly in their final positions as intended.There was no direct or increased risk of harm to a critical structure (e.G.Spinal cord, nerves, blood vessels, etc.) due to the misplaced screws.There was no harm or negative clinical effect to the patient due to the incorrect screw placement, neither for the negligible prolongation of anesthesia.There were no further medical or surgical remedial actions necessary, done or planned for this patient.Hospitalization was not prolonged.

• 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 boyle ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 11627902
• MDR Text Key: 261111991
• Report Number: 8043933-2021-00024
• 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: K183605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• 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: 22268-01C
• Device Lot Number: SW V. 1.5.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• 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