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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Synthes (canada) ltd. received notification from its supplier synthes usa that a medical device recall was being initiated for the matrix coronal bender part numbers 03.632.040 and 03.632.041 due to complaints received for reported bender tips breaking while surgeons are attempting to bend a spinal rod. the majority of complaints involve attempts to bend the warm-worked cobalt chrome (cocr) rods that are part of the matrix system. the failure mode of the tips on the returned field product consisted of a brittle fracture of the proximal tip (i.E. the tip closest to the surgeon).