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 Problem Use of Device Problem (1670)

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

Event Date 09/22/2022

Event Type  Injury  

Event Description

A minimally invasive surgery on the thoracic and lumbar spine for a fusion of vertebrae t11 to l3, due to a fractured l1 vertebra, with intended placement of 6 spine 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: with the patient in prone position, attached the navigation reference array on the spinous process of vertebra t10.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 accepted the accuracy to proceed.Starting with left t11, used the navigated pedicle access needle (pan) to determine the screw trajectory and to create the pilot holes for the spine screws in the vertebrae.Inserted k-wires through the navigated tube of the pan into the prepared pilot holes.After placing the last k-wire in left l3, acquired intra-operative placement verification c-arm fluoro shots, and determined that the k-wire in left l3 deviated from its intended position with a lateral shift of approx.3mm.Decided to remove the misplaced k-wire from left l3, and re-placed it to its intended position under fluoroscopic guidance with the c-arm.Placed the cannulated spine screws with a not navigated non-brainlab screwdriver, following the k-wires, into the pilot holes t11-l3.Completed the fusion surgery successfully as intended and closed the patient.According to the hospital (clinical admin./supervisor): the deviation of 1 of the 6 spine k-wires placed with the aid of navigation was detected by the surgeon with intra-operative c-arm fluoro shots before finalizing the surgery, and this placement was addressed under fluoroscopic guidance 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 to harm a critical structure by the deviating placement.There was no harm nor negative effect to the patient due to the deviating initial placement, and there was no surgery/anesthesia delay for the patient.There were further no remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a pilot hole and k-wire was placed in the patient's spine in a different position than desired with navigation involved, although according to the hospital: the deviation of 1 of the 6 spine k-wires placed with the aid of navigation was detected by the surgeon with intra-operative c-arm fluoro shots before finalizing the surgery, and this placement was addressed under fluoroscopic guidance 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 to harm a critical structure by the deviating placement.There was no harm nor negative effect to the patient due to the deviating initial placement, and there was no surgery/anesthesia delay for the patient.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 of the k-wire placement in the vertebra l3 left side deviating with a lateral shift of approx.3mm from the intended position, was: a relative movement of the anatomy during the surgery between the vertebra the patient reference array was fixated to (t10), and the vertebrae operated on (esp.L3) due to a non-rigid connection of these and forces applied to the spine.Fractures in between (at vertebra l1) were present reducing the stability of the spine, and high mechanical forces (hammering) were necessary to enter the sclerotic bone at left l3, as well as further high (hammering) forces in that spine area were applied beforehand to place the other screws.Multi-level navigation i.E.Operating on a different vertebra than the one the patient reference array for navigation is fixated to or operating across multiple vertebrae without remounting the patient reference and reregistering especially if the connection in between the vertebrae is not rigid results in relative movements of the vertebrae (actual anatomy) during the surgery that cannot be compensated by the navigation software displaying instrument positions on the registered pre-placement patient image scan.Apparently, the resulting deviation between the actual patient anatomy location during the placement and the registered preplacement patient image scan displayed by the navigation was not recognized by the user with the necessary and adequate navigation accuracy verification throughout the procedure, before and during preparation and placement of the k-wire in left l3.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 re-iterate 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
• 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: 15623327
• MDR Text Key: 301915918
• Report Number: 8043933-2022-00058
• 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: Physician
• Type of Report: Initial
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• 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: 22268E
• Device Lot Number: SW V. 1.5.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• 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