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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Rotational forces on the 16082 dowel pin during deploying or folding can cause the pin to slowly "screw" its way out of position. if the pin migrates enough to allow the brace to detach from the leg pivot fitting while a patient is ambulating with weight on the handles the product could slump to one side. this may cause the patient to stumble .