Alerte De Sécurité sur SURGICAL NAVIGATION SOFTWARE FOR SKULL / ORL. Anvisa Registry n ° 80042070022.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The following factors may have a significant effect on the overall navigation accuracy of the device: (1) Large distance between the reference star and the region of interest; (2) Large changes in camera positioning relative to the reference star during the procedure. Such occurrences may intensify small inaccuracies resulting from specific steps of the complex navigation procedure. In the worst case scenario, such inaccuracies may result in inaccurate display of the instruments by the navigation system, compared to the actual anatomy of the patient. Brainlab has released a new version of Brainlab Cranial software (version 2.1.2) to fix the problem. Until the new software is installed, users of the product should follow the instructions already provided by the company "Measures to Improve the Precision of Skull Navigation" and read the warning message issued by the company for this field action.