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 22268-02A

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

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

Event Date 05/12/2022

Event Type  Injury  

Event Description

An open surgery (on (b)(6) 2022 ) on the spine for posterolateral spine fusion (psf) at vertebrae l3-l5 due to lumbar spondylolisthesis, with intended placement of 6 pedicle screws, was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 1.5.During the procedure the surgeon: with the patient in prone position, attached the 2-pin fixator with schanz pins and 3-sphere array at the right iliac crest.Acquired two intra-operative ct scans with automatic image registration, verified registration accuracy and accepted the 2nd registration to proceed (the 1st registration was done with inappropriate settings).Planned screw trajectories using the navigated drill.Started to place screws in the pedicles of l3-l5 using the following workflow: opened the pedicle with the navigated drill, (for some pedicles/depending on quality of bone) prepared the screw path in the pedicle with the navigated awl tip tap, and placed the screw following the prepared path with the navigated screwdriver during preparation of the pedicle at left l3 (after drilling before inserting the screw), detected a deviation of virtual display of navigation from actual patient anatomy addressed the deviation by recalibration of the screwdriver and re-drilling the pedicle at left l3, and continued with pedicle preparation and screw placement using the workflow above.Acquired a 3rd intra-operative ct scan for confirmation of screw placement and confirmed that all screws were placed correctly.According to the hospital: the pedicle opening/entry point that was not in the position as intended was corrected in the very same surgery.The outcome of the surgery was successful as intended, with all screws placed in their correct final positions as intended.There was no direct (or increased) risk of harm to a critical structure due to this issue.There was no actual harm/negative clinical effect to the patient due to this issue (there was also no delay of surgery/anesthesia time).There were no further medical/surgical remedial actions necessary, done or planned for this patient due to this issue; hospitalization was not prolonged either.

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a pedicle entry was performed in the patient's spine in a different position than desired with brainlab navigation involved, despite according to the hospital/surgeon: the pedicle opening/entry point that was not in the position as intended was corrected in the very same surgery.The outcome of the surgery was successful as intended, with all screws placed in their correct final positions as intended.There was no direct (or increased) risk of harm to a critical structure due to this issue.There was no actual harm/negative clinical effect to the patient due to this issue (there was also no delay of surgery/anesthesia time).There were no further medical/surgical remedial actions necessary, done or planned for this patient due to this issue; hospitalization was not prolonged either.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 posterolateral spine fusion (psf) at vertebrae l3-l5 due to lumbar spondylolisthesis, with intended placement of 6 pedicle screws, 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 2-pin fixator with schanz pins and 3-sphere array at the right iliac crest - acquired two intra-operative ct scans with automatic image registration, verified registration accuracy and accepted the 2nd registration to proceed (the 1st registration was done before skin incision and without placing the reference array) - planned screw trajectories using the navigated non-brainlab drill - started to place screws in the pedicles of l3-l5 using the following workflow: opened the pedicle with the navigated non-brainlab drill, (for some pedicles/depending on quality of bone) prepared the screw path in the pedicle with the navigated non-brainlab awl tip tap, and placed the screw following the prepared path with the navigated non-brainlab screwdriver - during preparation of the pedicle at left l3 (after drilling before inserting the screw), detected a deviation of virtual display of navigation from actual patient anatomy - addressed the deviation by recalibration of the drill and re-drilling the pedicle at left l3, and continued with pedicle preparation and screw placement using the workflow above - acquired a 3rd intra-operative ct scan for confirmation of screw placement and confirmed that all screws were placed correctly.According to the hospital: - the pilot hole that was not in the position as intended was corrected in the very same surgery (with aid of navigation); - the outcome of the surgery was successful as intended, with all screws placed in their correct final positions as intended; - there was no direct (or increased) risk of harm to a critical structure due to this issue; - there was no actual harm/negative clinical effect to the patient due to this issue ;(there was also no delay of surgery/anesthesia time); - there were no further medical/surgical remedial actions necessary, done or planned for this patient due to this issue; hospitalization was not prolonged either.

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since a pilot hole (to prepare pedicle screw placement) was created in the patient's spine in a different position than desired with navigation involved, although according to the surgeon: - the pilot hole that was not in the position as intended was corrected in the very same surgery (with aid of navigation); - the outcome of the surgery was successful as intended, with all screws placed in their correct final positions as intended; - there was no direct (or increased) risk of harm to a critical structure due to this issue; - there was no actual harm/negative clinical effect to the patient due to this issue (there was also no delay of surgery/anesthesia time); - there were no further medical/surgical remedial actions necessary, done or planned for this patient due to this issue; hospitalization was not prolonged either.H6: 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 placement of the pilot hole at left l3 was most likely a relative movement of the l3 vertebra in relation to the right iliac crest where the reference was attached during the surgery.The significant amount of forces applied with the navigated screwdriver increases the likelihood of a relative bone movement.Vertebrae movements relative to the navigation reference array during surgery cannot be recognized by the navigation when displaying tracked instrument positions.Apparently, the resulting deviation between the registered preoperative patient image displayed by the navigation and the actual patient anatomy was not recognized by the user with the appropriate and necessary accuracy verification during the procedure before/while preparing the pilot hole at left l3 (it was recognized after preparation of the pilot hole and before screw insertion though).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: 14629891
• MDR Text Key: 293549542
• Report Number: 8043933-2022-00033
• 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: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22268-02A
• Device Catalogue Number: 22268-02A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2021
• 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