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

Model Number 22268-01C

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2022

Event Type  Injury  

Event Description

An open surgery (on (b)(6) 2022 ) on the spine for c2-c4 fusion was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 1.5.1.During the procedure the surgeon: with the patient in prone position, attached the navigation reference clamp and array at c2.Performed the image registration (surface matching) to match the pre-operative ct and display of the navigation to the current patient anatomy, verified the registration and considered it inaccurate.Performed a second image registration, verified and accepted the registration, considering it to be acceptable for the procedure.Placed four screws using aid of navigation.Acquired an x-ray for verification of screw position and detected that the screw(s) placed in c2 deviate from their intended position (by 3-4 mm).Removed the screw(s) from c2.-continued the surgery without aid of navigation (but using fluoroscopy).According to the hospital/surgeon: the pedicle screw(s) not placed as intended with aid of navigation were removed in the very same surgery.There was no actual harm nor negative effect to the patient reported due to the deviating placement no further remedial actions for the patient were reported that would have been done, necessary or planned, nor was prolongation of hospitalization reported.

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since pedicle screw(s) was/were positioned in the patient's spine in a different position than desired with brainlab navigation involved, although according to the hospital/surgeon: the pedicle screw(s) not placed as intended with aid of navigation were removed in the very same surgery.There was no actual harm nor negative effect to the patient reported due to the deviating placement.No further remedial actions for the patient were reported that would have been done, necessary or planned, nor was prolongation of hospitalization reported.A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report to the fda upon completion of investigation.

Event Description

An open surgery (on (b)(6), 2022) on the spine for c2-c4 fusion, with intended placement of 4 pedicle screws, was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 1.5.1.A pre-operative ct scan acquired on the day of the surgery was used to reference the navigation display to.During the procedure the surgeon: - with the patient in prone position, attached the navigation reference clamp and 4-sphere array at c2.- performed the image registration (surface matching) to match the pre-operative ct and display of the navigation to the current patient anatomy, verified the registration and considered it inaccurate.- performed a second image registration, verified and accepted the registration, considering it to be acceptable for the procedure.- placed screws in left/right c2 by creating pilot holes using the navigated brainlab drill guide and inserting the screws using a non-navigated non-brainlab screwdriver following the pilot holes.- acquired an x-ray for verification of screw position and detected that the screws placed deviate from their intended position (by 3-4 mm inferiorly).- removed the screws from c2.- continued the surgery without aid of navigation (but using fluoroscopy).According to the hospital/surgeon: - the two pedicle screws not placed as intended with aid of navigation were removed in the very same surgery.- the surgery was continued/completed without aid of navigation, and the outcome of the surgery was successful as intended.- there was no direct (or increased) risk of harm to a critical structure due to this issue.- there was no actual harm nor negative clinical effect to the patient due to the deviating placement.- there were no further remedial actions for the patient necessary, done or planned as a result of the deviation, nor was prolongation of hospitalization required.

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 brainlab navigation involved, despite according to the hospital/surgeon: - the two pedicle screws not placed as intended with aid of navigation were removed in the very same surgery.- the surgery was continued/completed without aid of navigation, and the outcome of the surgery was successful as intended.- there was no direct (or increased) risk of harm to a critical structure due to this issue.- there was no actual harm nor negative clinical effect to the patient due to the deviating placement.- there were no further remedial actions for the patient necessary, done or planned as a result of the deviation, nor was prolongation of hospitalization required.H6: according to the results of this technical investigation and the (limited) information provided by the hospital, it can be concluded that the root cause of the two screws at c2 deviating inferiorly from its intended positions by 3-4mm, is movement of the reference array due to insufficient rigid fixation and or inadvertent forces applied to the reference array/clamp (e.G., draping, surrounding skin/soft tissue, instrumentation performed) at the surgery after registration was accepted.Specifically, since the reference array movement warning appeared four times while navigating on both sides of c2.Array movement would lead to a shift between the navigation display of the image dataset and the actual patient anatomy.Apparently, the resulting deviation between the registered preoperative patient image and the actual patient anatomy was not recognized by the user with the appropriate and necessary accuracy verification before and during screw placement at both sides of c2.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.H7: 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, PRODUCT CODE: OLO
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: andrea miller ; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• MDR Report Key: 13838356
• MDR Text Key: 293143267
• Report Number: 8043933-2022-00016
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2021
• 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