MAUDE Adverse Event Report: BRAINLAB AG NAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.6); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22268A

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 03/18/2024

Event Type  Injury  

Event Description

An open surgery on the thoracic and lumbar spine for a fusion of vertebrae t7 to l1, due to a fracture at the t10,t11 disc space from a car accident, was intended to be performed with the aid of the display by the brainlab navigation software spine & trauma 3d 2.6.During the procedure the surgeon: with the patient in prone position, attached the navigation reference array on the spinous process of vertebra t10.Used the navigated spine pointer for surface matching to acquire registration points on the bone of vertebra t10 to register the current patient anatomy to the navigation, matching it to a formerly acquired patient ct scan imported into the navigation.Verified the registration and accepted the navigation accuracy to proceed.Starting with vertebra right t8, used the navigated pointer to determine the location of the pilot hole for the intended screw placement.Used a not navigated non-brainlab drill to open the cortical bone at the determined location, and checked the opening with the navigated pointer.Aligned the navigated drill guide with instrument position display on the patient scan, and created the full pilot hole drilling through the drill guide.Detected cerebrospinal fluid (csf) appearing from the pilot hole, and addressed this csf leak immediately.Created the pilot hole at vertebra right t7 with the same navigated method, noticed csf leaking also from this pilot hole, and addressed also this csf leak immediately.Cancelled this surgery, closed the patient and took the patient for an mri scan.The surgeon determined that the pilot holes created had deviated from their desired positions by ca.4-5mm, causing medial breaches in the vertebrae operated on.As per the surgeon, there was a temporary loss of signal in the lower extremities of the patient, however the surgeon is unsure if this was caused by the csf leaks or due to the patient's -unrelated to the navigated pilot holes - hemodynamic/hypotensive cardiac complications that had occurred during this surgery.The patient has fully recovered meanwhile, i.E.Regained all their strength.A revision surgery for the intended placements took place on (b)(6), 2024 with successful outcome as intended of this revision surgery.According to the surgeon (treating clinician): the medial breaches of the vertebrae with cerebrospinal fluid (csf) leaks from the deviating pilot holes were detected and addressed immediately at the very same surgery.There was a temporary loss of signal in the lower extremities of the patient, however the surgeon is unsure if this was caused by the csf leaks or due to the patient's unrelated to the navigated pilot holes - hemodynamic hypotensive cardiac complications that had occurred during this surgery.The patient has fully recovered meanwhile, i.E.Regained all their strength.A revision surgery for the intended placements took place on (b)(6) 2024 with successful outcome as intended of this revision surgery.There was no further harm nor negative effect to this patient, also not due to the revision surgery repeat anesthesia.Hospitalization was not reported to have been prolonged either.

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since pilot holes were created in the patient's spine in a different position than desired with navigation involved, causing medial breaches of the vertebrae with cerebrospinal fluid (csf) leaks that needed to be addressed immediately, despite according to the surgeon (treating clinician): the medial breaches of the vertebrae with cerebrospinal fluid (csf) leaks from the deviating pilot holes were detected and addressed immediately at the very same surgery.There was a temporary loss of signal in the lower extremities of the patient, however the surgeon is unsure if this was caused by the csf leaks or due to the patient's unrelated to the navigated pilot holes - hemodynamic/hypotensive cardiac complications that had occurred during this surgery.The patient has fully recovered meanwhile, i.E.Regained all their strength.A revision surgery for the intended placements took place on (b)(6), 2024, with successful outcome as intended of this revision surgery.There was no further harm nor negative effect to this patient, also not due to the revision surgery repeat anesthesia.Hospitalization was not reported to have been prolonged either.H6: according to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the main root cause of the two spine pilot holes drilled with the aid of navigation at vertebrae right t7 and t8 deviating by ca.4-5mm from their planned intended positions, causing medial breaches with cerebrospinal fluid (csf) leak, is: an insufficient distribution of points acquired by the user on the vertebra bone surface for patient anatomy registration to navigation, that did not follow brainlab requirements instructions.Specifically, as navigation data provided by the hospital for this surgery show, the overall registration point acquisition by the user did not include points taken at different heights such as the sides of the spinous process as required.This caused the navigation software to not find an as accurate match in the region of interest as desired for this specific procedure, in between the preoperative image dataset and the actual patient anatomy.The navigation data provided indicates a resulting rotational shift of the pre-planned pre-registration points versus their point locations collected by the surgeon, after the registration was applied and accepted by the user, indicating an inaccurate anatomy (location) registration to navigation.This inaccuracy on the registered vertebra t10 increased the farther away the vertebra operated on (here t7 and t8) was from the registered vertebra.Apparently, the resulting deviation between the actual patient anatomy locations during the spine instrumentation and the registered pre-placement patient image scan displayed by the navigation for instrument position visualization, was not recognized by the user with the necessary navigation accuracy verification of the registration before accepting it, after draping, and throughout the surgery before and during performing significant invasive actions with the aid of navigation.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: NAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.6)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: markus hofmann ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 19105185
• MDR Text Key: 340229800
• Report Number: 8043933-2024-00024
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 04056481106591
• UDI-Public: 04056481106591
• 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: 04/15/2024

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: 22268A
• Device Catalogue Number: 22268A
• Device Lot Number: SW V. 2.6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• 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): Required Intervention; Other