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 is a remote possibility that the distal driver tip may become dislodged from the driver shaft if the instructions for use are not followed. lateral loading during insertion or extraction as contraindicated may cause a separation of the distal tip and driver shaft after successful insertion of the implant.