Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Us

FDA device recall Z-1082-2019 · posted 2019-04-15 · Terminated

Recall details

Recalling firm

Brainlab AG

Reason for recall

In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image reconstruction (the not-updated ACS view ), instead of displaying the desirable view representation Inline View , which is commonly used for navigating invasive instruments at the spine. This could lead the surgeon to be unable to determine the position of the navigated instrument. This might occur after a crash restore or after changing between different navigation workflows during the same patient treatment.

Action taken

The firm, BrainLab, notified their existing customer base by email on with a letter entitled "URGENT FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" 02/25/2019. The notice explained the issue, product and actions to be taken. The customers were instructed to do the following: "User Corrective Action: 1. Avoid workflow changes with already registered datasets, if possible. If not absolutely necessary (e.g., for intraoperative screw planning), avoid switching between the workflow application selections 3D Navigation Intraoperative Imaging and 3D Navigation during one patient treatment. 2. After restarting the application with a previously registered dataset (crash restore or workflow change), always activate and deactivate the sub-menu Orientation once to ensure that the correct, expected view representations are displayed for the current session. Please continue to follow the instructions and warnings as described in the user guide. Especially relevant is the following warning in the Brainlab Spine & Trauma 3D Navigation 1.0 Software User Guide: Before beginning any surgical step, always ensure that navigation accuracy can be sufficiently maintained. If a surgical step could easily lead to reference displacement, remount the reference at an optimal position with a reduced possibility of displacement, and then register and verify again. The following methods can be used to ensure accuracy is sufficient: - Landmark verification - Fluoroscopy (compare the instrument location in the fluoro image with the display on the navigation system)" Brainlab will provide all affected customers with a software revision of Spine & Trauma Navigation Software with the described issue corrected. Brainlab will actively contact you, starting in June 2019 to schedule the update. If you have any questions, contact the Customer Hotline: +49 89 99 15 68 1044 or +1 800 597 5911 (for US customers)

Root cause

Software design

Status

Terminated

Product code

HAW

Quantity affected

148 units

Distribution

Worldwide Distribution: US (Nationwide) and countries of: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Ecuador, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Kazakhstan,

Date initiated

2019-02-27

Date posted

2019-04-15

Date terminated

2019-07-10

Location

Munich, Germany

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