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.
데이터 추가 비고
원인
Recent findings suggest that non-ossur female mating adapters connected to ossur ankle male pyramids have caused early failure of the male pyramid connector. this is due to incompatible geometry of the female mating adaptors used and/or improper set up of the prothesis.