MAUDE Adverse Event Report: BRAINLAB AG SPINE & TRAUMA 3D (VERSION 2.6); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTACTIC, PRODUCT CODE: OLO

Model Number	22268A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An minimally invasive surgery on the lumbar spine for a posterior lumbar interbody fusion (plif) of vertebrae l4-l5, with intended placement of 4 vertebra screws bilateral for fixation (at l4-l5), was 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 iliac crest.- 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.- planned the incisions using a navigated pointer.- prepared the pedicle with a mallet to create a pilot hole with the navigated pedicle access needle.- inserted a k-wire, and proceeded with the same approach until all 4 k-wires in l4 and l5 were placed.- performed a decompression and placed tlif cage.- used a navigated screwdriver to place screws into l4 and l5 vertebral bodies and with that determined a minor navigation inaccuracy, but nevertheless continued the use of navigation as an aid.Further when when placing the screw at left l4, noted that the k-wire was difficult to remove and slightly bent.- acquired an intra-operative an intra-operative 3d (x-ray) scan to verify the screw placements.- determined that of 1 of the 4 screws placed with the aid of navigation (in left l4) deviated from its intended position.- decided to remove the deviating spine screw, and re-placed it to its correct position using the aid of navigation.- acquired another intra-operative an intra-operative 3d (x-ray) scan to verify the screw placements and determined them as acceptable.- completed the surgery successfully as intended and closed the patient.
Additional Manufacturer Narrative
B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since a pedicle screw was placed in the patient's spine in a different position than desired with brainlab navigation involved, despite according to the hospital/surgeon (treating clinician): - the deviation of 1 of the 4 pedicle screws placed with the aid of navigation was detected by the surgeon before finalizing the surgery, and the screw was corrected to its intended position with navigation at the very same surgery.- the final outcome of the surgery was successful as intended, with all screw placements correct at the end of the surgery.- there was no direct (or increased) risk to harm a critical structure due to the deviating placements.There was no harm nor negative effect to the patient due to the deviating initial placements, also not due to surgery/anesthesia prolong of 10 minutes.- there were further no remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.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.H6: according to the results of technical investigation and the limited information provided by the hospital, the investigation results could neither confirm nor disprove an actual contribution of the information provided by brainlab navigation to the deviating screw placement at left l4.In the case that the inaccurate screw placement at left l4 was related to the use of navigation, this was most like caused by a bent k-wire in combination with a relative movement of the vertebra operated on (l4) in relation to the bone where the reference was attached to during surgery (iliac crest) due to the surgical forces applied to the bone.This relative movement in combination with a previously bent k-wire, which requires more force to place a screw over, could have misled the surgeon, resulting in the deviating screw placement at left l4.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 (e.G.After decompression) - 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 registered preoperative patient image displayed by the navigation and the actual patient anatomy was not fully recognized by the user with the appropriate and necessary accuracy verification during the procedure before inserting the screw at left l4.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 user.

• Brand Name: SPINE & TRAUMA 3D (VERSION 2.6)
• Common Device Name: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTACTIC, PRODUCT CODE: OLO
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM
• Manufacturer Contact: julia mehltretter ; olof-palme-strasse 9; muenchen, 81829 ; GM
• MDR Report Key: 17773093
• Report Number: 8043933-2023-00062
• Device Sequence Number: 7022665
• Product Code: OLO
• UDI-Device Identifier: 04056481106591
• UDI-Public: 04056481106591
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2023

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
• Operator of Device: Health Professional
• Device Model Number: 22268A
• Device Catalogue Number: 22268A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown