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 06/17/2022

Event Type  Injury  

Event Description

An open posterior lumbar interbody fusion (plif) surgery on the spine for fusion at vertebrae l4-s1 to treat degenerative disc (discopathy), with intended placement of 6 bilateral 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, performed the initial incision and preparation of the bones for pedicle access (without navigation).Attached the navigation reference array on the spinous process of l5 (on what the surgeon believed to be the spinous process of l5; it was later determined during investigation it was actually attached to tissue in between l4 and l5).Acquired an intraoperative ct scan with automatic image registration of the current patient anatomy to the navigation, and verified and accepted the accuracy of the registration to proceed.Calibrated a the brainlab drill guide to the navigation, and verified and accepted the accuracy of the instrument to proceed.Used the navigated drill guide to align the drill to the intended trajectory for the screw path, drilled the pilot path in the pedicle, and used a non-navigated non-brainlab screwdriver to place screws down the prepared paths on the right side for l4, l5, and s1, and then repeated on the left side (l4-s1), for a total of 6 screws.Obtained a verification intraoperative ct scan, and determined the bilateral screw placements at l5 deviated from the intended positions by 1cm in the cranial direction, at the target position only (entry point determined to be correct).It was also noted that the screws at s1 were "at the limit/very close to the edge of the pedicle, almost perforating into the disc space", however these were deemed acceptable and no correction was deemed necessary.Removed the bilateral screws at l5 and decided not to replace/reposition them.Completed the rest of the surgery as planned.According to the surgeon: the two misplaced screws were detected with intraoperative imaging during the surgery and were removed; the surgeon decided not to replace/reposition the screws.The outcome of the surgery was successful as intended.There was no actual harm or negative clinical effect to the patient due to the misplaced screws, neither for the prolongation of surgery/anesthesia by 2.5 hours.There were no further medical or surgical remedial actions necessary, done, or planned for the patient due to this problem.Hospitalization was not prolonged either.

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 navigation involved, although according to the surgeon: the two misplaced screws were detected with intraoperative imaging during the surgery and were removed; the surgeon decided not to replace/reposition the screws.The outcome of the surgery was successful as intended.There was no actual harm or negative clinical effect to the patient due to the misplaced screws, neither for the prolongation of surgery/anesthesia by 2.5 hours.There were no further medical or surgical remedial actions necessary, done, or planned for the patient due to this problem.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 left and right l5 by ca.1cm from their intended target positions is movement of the navigation reference array due to insufficient rigid fixation by the user (i.E.Reference clamp not fully engaged on the vertebra, as required).The array movement software warning also appeared throughout the procedure, further indicating its occurrence of reference shift.A movement of the navigation reference array after patient registration to navigation disrupts the coordinate system established during the registration and causes a deviation between the displayed image scan on which navigated instruments are tracked, and the actual patient anatomy.This movement cannot be compensated by the navigation software.An additional minor contributing factor is movement of the patient anatomy between the vertebrae operated on (l5) and the reference's array's position (in between l4-l5).Operating across multiple vertebrae without re-fixing and reregistering the patient reference array can result in movements of the spine relative to the fixed reference array especially if forces are applied to the bone (e.G.During advancement of the instrument(s) into the bone).Movement of the patient's spine relative to the position of the reference array cannot be recognized by the navigation system and can result in an inaccurate display of tracked instruments on the registered patient image compared to its actual position on the patient anatomy.Apparently the resulting deviation of the navigation display was not recognized by the user with the necessary navigation accuracy verification throughout the procedure, and during the planning and placement of the screws at left and right l5.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.

• 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: 15076221
• MDR Text Key: 296323353
• Report Number: 8043933-2022-00043
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 04056481142025
• UDI-Public: 04056481142025
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K183605
• 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: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• 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: 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: 06/23/2022
• 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