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

Model Number 22268-01C

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 08/08/2022

Event Type  Injury  

Event Description

A surgery on the spine, with intended placement of vertebra screws, was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 1.5.During the procedure the surgeon: placed screws with the aid of brainlab navigation.Acquired an intra-operative verification x-ray image, and determined that one screw, that had been placed with the aid of navigation, deviated from its intended position.Decided to remove and replace the screw.According to the surgeon (treating clinician): the deviation of the spine screw placed with the aid of navigation, was detected by the surgeon with an intra-operative x-ray image before finalizing the surgery, and these placements were addressed at the very same surgery.There was no negative clinical effect to the patient reported by the hospital, nor any medical/surgical remedial action that would have been necessary, done or planned for this patient due to this issue (besides replacement of the misplaced screw).

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a pedicle screw was positioned in the patient's spine in a different position than desired with brainlab navigation involved, although according to the hospital/surgeon: the deviation of the spine screw placed with the aid of navigation, was detected by the surgeon with an intra-operative x-ray image before finalizing the surgery, and these placements were addressed at the very same surgery.There was no negative clinical effect to the patient reported by the hospital, nor any medical/surgical remedial action that would have been necessary, done or planned for this patient due to this issue (besides replacement of the misplaced screw).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

A minimally invasive surgery on the lumbar spine on l2 - l4 for extension of fusion at l4 and revision at l2-l3, with intended placement of 6 vertebra 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 navigation reference array on the spinous process of vertebra l1.- acquired an intra-operative 3d (x-ray) scan of the patient's region of interest with automatic image registration of the current patient anatomy to the navigation.- verified the registration and accepted the accuracy to proceed.- made an incision at l4 left, and placed a screw with the aid of a navigated brainlab pointer and navigated non-brainlab drill and screwdriver.- performed the very same approach at right l4 for screw placement, but with the additional aid of soft tissue dilators - acquired an intra-operative verification x-ray image, and determined that the screw at left l4, that had been placed with the aid of navigation, deviated from its intended position.- decided to remove and replace the screw with the aid of navigation (using the same registration), including changing from minimal invasive to an open surgery approach.- used the aid of navigation to place a lateral cage, including an intermittent loosening of the reference array due to malleating, followed by refixing of the reference array and confirming accuracy.- some time after the placement observed a deviation of the navigation display compared to the actual patient anatomy and performed a new automatic image registration.- placed bilateral pedicle screws at l2 and l3 with the aid of navigation.According to the surgeon (treating clinician): - the deviation of the spine screw at left l4 placed with the aid of navigation, was detected by the surgeon with an intra-operative x-ray image before finalizing the surgery, and the placement was addressed with navigation (using the same registration) at the very same surgery.- the final outcome of this surgery was successful as intended, with the placements correct at the end of the surgery.- there was no harm nor negative effect to the patient due to the deviating initial placement reported to brainlab, also not due to changing from minimal invasive to an open surgery approach nor due to the needed double surgery/anesthesia time for the patient.- there were further no reports of remedial actions for the patient done, necessary or planned, neither any prolongation of hospitalization.

Manufacturer Narrative

Based on the results of technical investigation and the information provided by the hospital, it can be concluded that this adverse event (pedicle screw positioned in the patient's spine in a different position than desired) is actually unrelated to the use of the brainlab navigation device.There is no indication of an error or malfunction of the brainlab navigation device, nor of an error related to the use of the device.H6: according to the results of this technical investigation and the information provided by the hospital, it can be concluded that the root cause of the pedicle screw at left l4 having been placed more lateral than intended was due to factors unrelated to brainlab navigation.Based on the information provided for the investigation, there is no indication that brainlab navigation was inaccurate during the procedure and therefore no indication that the brainlab navigation software nor brainlab products contributed to the misplacement of the screw at left l4.Specifically, the difficult surgical approach (mis) and no dilators used for the first/affected screw placed (left l4) in combination with the likely poor bone quality and surrounding skin/soft tissue caused the instrument(s) and subsequent screw to deviate from their planned positions.The intraoperatively planned screw trajectory saved indicates that its entry point was on such steep/narrow bone and would be more likely for the instruments (3rd party drill and 3rd party screwdriver) to slip and deviate from their planned positions.Furthermore, the automatic screenshots taken during the surgery show that after drilling was performed, the pointer was positioned laterally on the bone which supports the claim that the previously used navigated instruments most likely slipped and deviated.Apparently, the deviated path of the instruments in the pedicle bone during screw insertion at left l4 was not recognized in the (accurate) navigation display by the user (assumedly because the navigation display was not observed closely enough by the user during advancement of the screw in the bone).There is no indication of an error or malfunction of the brainlab navigation device.

• Brand Name: SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTACTIC
• 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: julia mehltretter ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 15379435
• MDR Text Key: 299470651
• Report Number: 8043933-2022-00052
• 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: K212245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2022
• 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