Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
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There are specific pairs of arrays that might add an inaccuracy of more than 1 mm to the registration result during the exchange due to the combination of their tolerance limits. this effect could potentially cause an inaccurate display of instruments by the navigation system in the region of interest compared to the actual patient anatomy.