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 Problem Use of Device Problem (1670)

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

Event Date 09/07/2022

Event Type  Injury  

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 (treating clinician): the deviation of the spine screws placed with the aid of navigation was detected by the surgeon with an intra-operative c-arm scan 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 harm nor negative effect to the patient due to the deviating initial placements, also not due to the surgery/anesthesia prolong of ca.1 hour.There were further no remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.According to the results of this technical investigation and information provided by the hospital, it can be concluded that the root cause of the misplacement of the right screws is: relative movement of the anatomy between t12 (patient reference array fixation) and the other vertebrae (i.E.L1, t9, t10, t11) (operated region of interest) due to a non-rigid connection and/or forces applied on the anatomy.Apparently, the resulting deviation of the anatomy location displayed by the navigation was not recognized by the user with the necessary navigation accuracy verification throughout the procedure, before and during preparing and performing the screw placements in the spine.A misplacement of the right t12 screw could not be explained by relative movement, as the patient reference was attached to this vertebra.However it could not be finally confirmed, whether this screw was also misplaced or not.In case this screw was also misplaced, the root cause could be a missing re-calibration of the screwdriver with the new screw mounted.A possible not inline mounted screw could have caused a deviation.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.

Event Description

A minimally invasive surgery on the thoracic and lumbar spine on vertebrae t9 - l1, with intended placement of 10 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 t12.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.Calibrated non-brainlab instruments (burr and screw driver) to the navigation for instrument position display.Placed vertebra screws with the aid of navigation (5 screws on the left side, 5 screws on the right).Acquired a verification intra-operative c-arm scan, and determined that the screws placed at the right side of the vertebras deviated from its intended position.Decided to remove the screws and to re-place them without the aid of navigation.Completed the surgery successfully as intended and closed the patient.According to the surgeons (treating clinicians): the deviation of the spine screws placed with the aid of navigation was detected by the surgeon with an intra-operative c-arm scan 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 harm nor negative effect to the patient due to the deviating initial placements, also not due to the surgery/anesthesia prolong of ca.1 hour.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, 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: 15543844
• MDR Text Key: 301189576
• Report Number: 8043933-2022-00056
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 04056481142025
• UDI-Public: 04056481142025
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K212245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• 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: 22268-01C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2021
• 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