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

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 06/18/2022

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a screw trajectory was created in the patient's spine in a different position than desired with navigation involved, although according to the surgeon: the one screw trajectory that was not in the position as intended was revised in the very same surgery (without aid of navigation).The outcome of the surgery was successful as intended, with all screws placed in their correct final positions as intended.There was no direct (or increased) risk of harm to a critical structure due to this issue.There was no actual harm/negative clinical effect to the patient due to this issue (also not due to delay of surgery/anesthesia time of about 30-60 min).There were no further medical/surgical remedial actions necessary, done or planned for this patient due to this issue; 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 following factor contributed to the deviating placement of the trajectory within the left pedicle of vertebra l3: a less than ideal point acquisition by the user during the patient registration, not completely following brainlab recommendations as required (points not spread widely enough over the patient's vertebra), which caused the brainlab navigation software to not find a match between the display of the preoperative image dataset and the actual patient anatomy that was as accurate as required for this specific procedure (but led to a less than ideal result of the surface matching registration and thus a deviation of the pedicle entry point and rough trajectory angle determined using aid of navigation).The less than ideal surface matching result was apparently not recognized by the surgeon before determining the entry point and creating the trajectory, with the required navigation accuracy verification after registration, and throughout the procedure.Details: at a later surgery step, the screw trajectory at left l3 was re-checked/re-verified and the deviation of the trajectory as shown on the navigation display appeared to be larger than when detected initially, but that was due to another less than ideal result of the subsequent surface matching registration for the same reasons as described above, i.E.The actual deviation of the trajectory was less than the deviation displayed by navigation.Note: it cannot be assessed if/to which extent the non-navigated drilling may have potentially contributed to the deviating placement of the screw trajectory at left l3.(the surgeon used the navigated brainlab pointer only to define the entry point and rough angulation of the pedicle and for the creation of the trajectory with non-navigated non-brainlab instruments he either tried to remember the position of the pointer or used his anatomical knowledge only.Thus a potential deviation could also have occurred during this non-navigated surgery step).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

An open surgery (on (b)(6) 2022) on the spine for a posterior fusion of vertebrae l3 to s1, with intended placement of 8 pedicle screws, was performed with the aid of the display by the brainlab navigation software spine & trauma 3d 1.5.1.During the procedure the surgeon: with the patient in prone position, attached the 4-sphere navigation reference array with the reference clamp carbon to different spinous processes (unknown when exactly placed at which spinous process).Performed multiple image registrations (surface matching at different levels) to match the pre-operative ct and display of the navigation to the current patient anatomy, verified and accepted the registrations to proceed.Created screw trajectories (mostly at the level registration was performed and/or at the level below) using the brainlab pointer to determine the pedicle entry point and rough trajectory angle, and using a non-navigated non-brainlab drill and probe to open the cortical bone and create the trajectory.After creation of screw trajectories at l3 (with reference clamp and array at s1 and registration/surface matching at l2), detected a deviation of the trajectory created at left l3 from the intended position (by comparing the position and angle of this trajectory with patient anatomy).Performed new image registrations (surface matching at l3) to re-verify the (deviation of) trajectory at left l3.Revised the trajectory at left l3 without aid of navigation (using x-ray).Placed screws without aid of navigation (using a c-arm).According to the hospital/surgeon: the one screw trajectory that was not in the position as intended was revised in the very same surgery (without aid of navigation).The outcome of the surgery was successful as intended, with all screws placed in their correct final positions as intended.There was no direct (or increased) risk of harm to a critical structure due to this issue.There was no actual harm/negative clinical effect to the patient due to this issue (also not due to delay of surgery/anesthesia time of about 30-60 min).There were no further medical/surgical remedial actions necessary, done or planned for this patient due to this issue; hospitalization was not prolonged either.

• Brand Name: SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC, PRODUCT CODE: OLO
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: andrea miller ; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• MDR Report Key: 15010547
• MDR Text Key: 295861402
• Report Number: 8043933-2022-00040
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 04056481142025
• UDI-Public: 04056481142025
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K183605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• 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: 06/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other