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
Impaction forces may fracture the welds holding the striker plate to the rasp handle. this may lead to fatigue stress fractures and disassociation of the strike plate from the rasp handle. the surgeon may proceed with the surgery by removing and replacing the brocken rasp handle. an extension of surgery time of around 30 minutes is required to fix the device.