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

Model Number 22268-02A

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Naturally Worn (2988)

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

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a k-wire was placed in the patient's spine in a different position than desired with navigation involved, although according to the surgeon (treating clinician): the deviation of one of the k-wires placed was detected by the surgeon with intra-operative c-arm shot (x-ray) before placing its following spine screw and before finalizing the surgery, and this placement was addressed 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 direct (or increased) risk of harm to a critical structure due to the deviating initial k-wire placement into the spine.There was no harm nor negative effect to the patient due to the placement, also not due to the surgery/anesthesia prolong of ca.10min.There were further no remedial actions for the patient done, necessary or planned.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 for the 2mm cranial entry with caudal angle of deviation at the left l5 k-wire is: an inaccurate registration of the intraoperative fluoroscopic 3d scan to the navigation, caused by a decalibrated non-brainlab c-arm in combination with dull/worn reflective marker disks of the brainlab fluoro 3d (registration) kit attached to the non-brainlab c-arm, both due to the required maintenance/inspection not being followed as required.Specifically for the brainlab fluoro 3d kit, it has been in use at the customer site since 2007; brainlab recommends periodic inspection and maintenance, including replacement of any dull/worn marker disks.As distance from the reference array increases, the potential for deviation increases which could explain the single area deemed inaccurate by the surgeon during verification.Therefore, to a lesser degree a further contributing factor was the multi-level navigation performed in this case: operating on a different vertebra level (l5) than that on which the reference array is attached (iliac crest).Particularly in this case, this contributing factor is indicated since the deviation was observed on the level that was the furthest navigated point from the patient reference array.The resulting deviation of the navigation display was recognized by the user with the necessary and required accuracy verification after the registration of the intraoperative fluoroscopic scan to the navigation.However, the surgeon chose to proceed with using the aid of navigation to place a k-wire in the same anatomical area that displayed the detected deviation, which is outside brainlab recommendations.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

An open surgery on the lumbar and sacral spine for posterior lumbar interbody fusion (plif) of vertebrae l5 and s1, due to spondylolisthesis l5/s1, with intended placement of 4 vertebra screws bilateral for fixation, was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 1.5.During the procedure the surgeon: placed implants in the disc space between vertebrae l5 and s1 without use of navigation, and filled them with autograft.With the patient in prone position, attached the navigation reference array with 2 schanz pins to the right iliac crest.Acquired an intra-operative c-arm scan of the patient's region of interest with automatic image registration of the current patient anatomy to the navigation.Verified the registration, and noted a deviation of the navigation's instrument position display compared to the actual patient anatomy only on the left side of l5, and since the registration was sufficiently accurate on all other spots of the region of interest verified - i.E.On the right side l5 and both sides s1 - accepted the navigation accuracy to proceed.Starting with left l5, used the navigated drill guide 1.8mm with trocar insert to mallet the trocar into the vertebra by ca.3-5mm, and to drill a k-wire through the drill guide into the vertebra.Since the surgeon was not confident with the k-wire placement, performed an intra-op verification c-arm shot (x-ray), and determined that the k-wire placed in left l5 deviated from its intended position, angulated and by ca.2mm too high.Decided to remove this k-wire, and to re-place it to its intended position without using the aid of navigation, and verified its corrected position with another x-ray.Threaded the hole following the k-wire placed, with a not navigated non-brainlab tap, and placed the vertebra screw also following the k-wire with a not navigated non-brainlab screwdriver.Placed the other 3 k-wires in l5 and s1 with the navigated drill guide and the same navigated method as before, tapped and placed the remaining screws into the vertebrae with the not navigated instruments following the k-wires.Completed the surgery successfully as intended and closed the patient.According to the surgeon (treating clinician): the deviation of one of the k-wires placed was detected by the surgeon with intra-operative c-arm shot (x-ray) before placing its following spine screw and before finalizing the surgery, and this placement was addressed 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 direct (or increased) risk of harm to a critical structure due to the deviating initial k-wire placement into the spine.There was no harm nor negative effect to the patient due to the placement, also not due to the surgery/anesthesia prolong of ca.10min.There were further no remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.

• 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: 16584232
• MDR Text Key: 311744038
• Report Number: 8043933-2023-00025
• 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: 02/22/2023

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: 22268-02A
• Device Catalogue Number: 22268-02A
• 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: 02/22/2023
• Initial Date FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• 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