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 09/23/2021

Event Type  Injury  

Event Description

A surgery on the cervical spine for fusion from vertebra c2-t1, with intended placement of 10 pedicle screws for fixation for a patient presenting with spondylolisthesis, was performed with the aid of the display by the brainlab software spine & trauma 3d navigation 1.5.During the procedure the surgeon: positioned the patient prone on the operating table, attached a headholder to the patient, and attached the brainlab patient reference to the headholder.Created a small incision over the area of interest of the cervical spine, placed the brainlab small incision matrix, and draped the patient for the intraoperative ct scan.Acquired an intraoperative ct scan with automatic image registration of the current patient anatomy to the navigation.Removed the scanning drapes, and verified and accepted the accuracy of the registration to proceed, removing the small incision matrix that was used for registration.Created paths in the pedicles (left and right) of c7 using the navigated drill guide, and placed screws in the prepared paths using a non-navigated non-brainlab screwdriver.Determined using the navigated pointer that there was a deviation in the display of navigation compared to the patient anatomy on vertebrae c6 and c5, about 3mm in the lateral direction.Placed the small incision matrix and performed another intraoperative ct scan with automatic image registration of the current patient anatomy to the navigation.Determined that the right c7 screw was placed too lateral and removed this screw.(initially it was reported by the surgeon that the left and right c7 screws were misplaced, and that both were repositioned during the surgery, but brainlab's review of the scans and logfiles showed that only the right c7 screw was misplaced and was simply removed, while the left c7 screw placement appeared correct and was never removed or repositioned.) verified the accuracy of the second registration and determined there was still a deviation between the display of navigation compared to the patient anatomy, and so performed a third ct scan and registration in the same method, but using the minimally invasive matrix instead of the small incision matrix.Verified and accepted the accuracy of the third registration to proceed.Used the navigated drill guide to prepare paths in the pedicles of c6 and c5, and placed the screws down the paths using the non-navigated screwdriver.Lowered the patient table, and afterwards detected a deviation between the display of navigation and the patient anatomy again.The surgeon decided to discontinue the use of navigation, and placed the remaining screws using conventional methods.(additionally, instead of some pedicle screws - supposedly at c3 - the surgeon instead placed lateral mass screws at c2.It is not known if this change in surgical plan was related to the discontinued use of navigation, the misplaced c7 screw, or an unrelated reason.) completed the surgery successfully, and determined via a final confirmation ct scan that all screws were placed correctly.According to the surgeon: the deviating screw was detected using an intraoperative scan before the surgery was completed, the screw was removed during the very same surgery, and the surgeon decided not to replace it.(despite the surgeon initially reporting that both left and right c7 screws were misplaced and re-positioned during the surgery, a review of the scans showed that only the right c7 screw was misplaced, and it was removed and not replaced.) the outcome of the surgery was successful; all screws were successfully placed at the end of the surgery.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 screw.There was no actual harm/negative clinical effect to the patient due to the incorrect placement of screws, nor for the prolonged anesthesia of one hour.There were no (further) medical or surgical remedial actions necessary, done or planned for this patient.Hospitalization was not prolonged either.

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since screws were placed in the patient's spine in a different position than desired with navigation involved, although according to the surgeon: the deviating screw was detected using an intraoperative scan before the surgery was completed, and the screw was removed during the very same surgery, and the surgeon decided not to replace it.(despite the surgeon initially reporting that both left and right c7 screws were misplaced and re-positioned during the surgery, a review of the scans showed that only the right c7 screw was misplaced, and it was removed and not replaced.) the outcome of the surgery was successful; all screws were successfully placed at the end of the surgery.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 screw.There was no actual harm/negative clinical effect to the patient due to the incorrect placement of screws, nor for the prolonged anesthesia of one hour.There were no (further) medical or surgical remedial actions necessary, done or planned for this patient.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 of the screw misplacement at the right pedicle of c7, by approximately 2mm lateral from its intended trajectory, was most likely a relative movement of the vertebra c7 in relation to the skull to which the reference array was attached.The relative movement was supported by the in general mobile cervical spine and the indication of an instable spine.A further indication of a relative movement is the report that the accuracy was lost after the patient table was lowered.This causes movement of the patient / spine and can possibly be an additional reason for the relative movement at the cervical spine.A possible contributing factor is a potential movement of the brainlab universal air matrix during the registration and scan, in relation to the patient reference, resulting in a registration that was not as accurate as desired for this specific surgery, due to not following brainlab's recommendations for registration: the patient's breathing was not halted during the scan, and the sterile drape was attached in a way that could pull/move the matrix.For the registration and during the scan, the positions between the universal air matrix and the patient reference must not change.Apparently, the resulting deviation between the registered patient image and the patient anatomy was not recognized by the surgeon during the procedure of inserting the c7 pedicle screws and during or after the initial accuracy verification was accepted.A further possible contributing factor is that the screw placement made with the non-navigated screwdriver could have diverted from the prepared path made with the aid of the navigated drill guide.The navigated procedure included the pointer and the drill guide only.Once the trajectory was prepared for the screw, the screw was inserted without navigation.It is possible that the screw can deviate from the intended trajectory when placed with a non-navigated screwdriver.Any resulting deviation of the screw from the prepared path would thus not be caused or contributed by navigation or its use.However the extent of any such deviation was not able to be assessed by brainlab with the scans provided by the customer (could not be determined looking at the small anatomy on the scans whether the screw followed the prepared path or not).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
• MDR Report Key: 12674500
• MDR Text Key: 282348045
• Report Number: 8043933-2021-00069
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 04056481142025
• UDI-Public: 04056481142025
• Combination Product (y/n): N
• PMA/PMN Number: K183605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• 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
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other