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 06/20/2022

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 navigation involved, although according to the surgeon: the three misplaced screws were detected by intraoperative imaging during the surgery, and were successfully repositioned to their intended positions using navigation during the very same surgery.The outcome of the surgery was successful with all screws placed in their intended positions at the end of the surgery.There was no increased risk of harm due to the screw misplacements, nor was there any actual harm or negative clinical effect to the patient due to the screw misplacements.There was no prolongation of anesthesia/surgery due to the problem, and hospitalization was not prolonged either.There were no further medical or surgical remedial actions necessary, done, or planned for this patient.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the main root cause for the misplaced pedicle screws (at left t4 and bilaterally at t3), deviating from their intended target positions by ca.3mm (or 10 degrees) is: a relative movement of the t3 and t4 vertebrae (where the surgeon was operating) in relation to the vertebrae upon which the navigation reference was attached (by a rod to the screws at t11-l1) during the surgery, due to forces applied to the bone during instrumentation e.G.Use of the probe.Operating across multiple vertebrae using a single registration 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.Movement of the patient's spine relative to the position of the fixed 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.As an additional minor contributing factor (to a much lesser extent): movement of the navigation reference array during surgery in relation to its fixation (by use of non-brainlab revision rod attachment at right side screws l1, t12, and t11), due to an insufficient rigid fixation by the user.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.Additionally, the non-brainlab reference fixation system used in this surgery has not been officially tested or validated by brainlab and therefore brainlab is not in a position to determine its compatibility or accuracy in its use with brainlab navigation and brainlab instruments.Apparently, the full extent of the resulting deviation in the navigation display was not recognized by the user with the necessary navigation accuracy verification throughout the procedure, and during planning and placement of the screws at left and right t3 and right t4.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 surgery on the thoracic and lumbar spine for a posterior spinal fusion to correct scoliosis from t3-l2, with intended placement of 23 pedicle screws, was performed with the aid of the display by the brainlab navigation software spine & trauma 3d navigation 1.5.During the procedure the surgeon: with the patient in prone position, performed the initial incision and exposure, and attached the brainlab navigation reference array on the spinous process of l2 (using the brainlab reference clamp).Calibrated the brainlab drill guide and a non-brainlab probe, tap, and screwdriver to the navigation, and accepted the accuracy of the calibrations to proceed.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.Placed bilateral pedicle screws using the navigated instruments (pointer, tap, and screwdriver) from t10 to l2 (10 screws total).Removed the navigation reference array and reference clamp.Attached a non-brainlab revision rod (pre-bent rod) at the right pedicle screws of l1, t12, and t11, and attached the brainlab navigation reference array to this rod using a non-brainlab ex-fix clamp (note: this method of attachment of the reference array is not recommended by brainlab).Acquired a second intraoperative ct scan with automatic image registration of the current patient anatomy to the navigation (it was observed on this scan that the previously placed 10 screws were in the correct positions).Verified the automatic registration and determined there was a slight deviation between the actual position of the pointer on the patient's anatomy and the displayed position of the pointer on the intraoperative ct in the navigation software, only at t3 and t4 - it was noted the navigated pointer appeared slightly embedded in the bone in the navigation display, despite its position was actually on the surface of the bone.The placement of the pointer on the other vertebrae displayed no similar deviation and the registration was confirmed to be accurate on the vertebral levels caudal to t4.Accepted the accuracy of the registration to proceed, despite the observed deviations at t3 and t4.Placed pedicle screws using the same navigated instruments as before, with the addition of the navigated probe to help prepare the screw path, on the right side from t3 to t8, and then repeated for the left side at these same vertebrae.Performed another intraoperative ct scan with automatic image registration, and determined via the scan that the right t3 screw was lateral and the left t3 and t4 screws were medial to their intended target positions (all by ca.3mm or 10 degrees); the surgeon noted that the deviation of these screws was more significant than the original deviation of navigation observed at t3 and t4 during the accuracy verification step performed earlier.Verified the accuracy of the registration of this final ct scan, accepted it to proceed, and repositioned the three screws to the intended positions using the same navigated instruments as before.Completed the surgery successfully.According to the surgeon: the three misplaced screws were detected by intraoperative imaging during the surgery, and were successfully repositioned to their intended positions using navigation during the very same surgery.The outcome of the surgery was successful with all screws placed in their intended positions at the end of the surgery.There was no increased risk of harm due to the screw misplacements, nor was there any actual harm or negative clinical effect to the patient due to the screw misplacements.There was no prolongation of anesthesia/surgery due to the problem, and hospitalization was not prolonged either.There were no further medical or surgical remedial actions necessary, done, or planned for this patient.

• 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: 15019411
• MDR Text Key: 295954319
• Report Number: 8043933-2022-00042
• 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
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• 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