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

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

Event Date 11/24/2021

Event Type  Injury  

Event Description

An open surgery on the spine for fusion at vertebra c7, with intended placement of pedicle screws in c7 for fixation, was performed with the aid of the display by the brainlab software spine & trauma 3d navigation 1.5.However, the overall intention and full extent of the surgical details was not provided by the hospital (e.G.Which levels were intended to be fused with c7 and if/where other screws/rods were planned for placement).During the procedure the surgeon: positioned the patient, performed the initial exposure, and attached the navigation reference array on the spinous process of c7.Performed the patient registration on the preoperative ct acquiring registration points on the laminae and spinous process of the patient's c7 vertebra to match the display of the navigation to the current patient anatomy, and verified and accepted the accuracy of the navigation to proceed.Used the navigated drill guide to align a drill to the intended trajectory at the left and right pedicles of c7, and drilled paths for the screws.The drill guide and pointer were the only navigated instruments.The hospital did not provide any further information regarding other instruments used for screw placement.Placed the screws down the prepared paths at left and right c7.The hospital did not provide any further information regarding if any additional screws were placed in any other vertebrae.At some point during the surgery, (potentially after the incision was closed) the surgeon obtained fluoroscopic images which showed the screws were placed at t1 and not c7 as planned.Information regarding the amount and degree of the deviation from the intended location was not provided by the hospital.The screws were repositioned during the surgery to the intended locations at c7.According to the hospital: there was only a need to repeat the exposure and reposition the two screws.Information about the overall outcome of the surgery was not provided by the hospital.There was no actual harm or negative effect to the patient due to the misplaced screws.There was no report of any harm or negative effect due to the prolonged anesthesia for the repositioning of the screws.(the indication on the initial medwatch by the customer that the patient died was an error in the user's submission.) there was no report of any further remedial medical/surgical actions that would have been necessary, done, or planned for this patient.There was neither any report of prolonged hospitalization.

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since pedicle screws were placed in the patient's spine in a different position than desired with navigation involved, although according to the hospital: there was only a need to repeat the exposure and reposition the two screws.Information about the overall outcome of the surgery was not provided by the hospital.There was no actual harm or negative effect to the patient due to the misplaced screws.There was no report of any harm or negative effect due to the prolonged anesthesia for the repositioning of the screws.(the indication on the initial medwatch by the customer that the patient died was an error in the user's submission.) there was no report of any further remedial medical/surgical actions that would have been necessary, done, or planned for this patient.There was neither any report of prolonged hospitalization.According to the results of the brainlab investigation and limited information provided by the hospital, it can be concluded that the root cause for the reported misplacement of the 2 pedicle screws at t1 (instead of c7) can be attributed to: an insufficient distribution of points acquired by the user for patient anatomy registration to navigation that did not follow brainlab requirements.Specifically, the overall point acquisition did not include points taken at different heights such as the sides of the spinous process, and points were collected on a different level (c6) than where the reference was placed and where the initial 3 registration points were planned (c7).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.Apparently, the resulting deviation in the navigation was not detected by the user with the appropriate and necessary verification checks after registration (at the verification step) and/or prior to (or during) planning and placing the pedicle screws.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.

• 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 boyle ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 13548652
• MDR Text Key: 285743610
• Report Number: 8043933-2022-00010
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• 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
• Device Lot Number: SW V.1.5.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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