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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Complaints have been received which describe the synfix lr implant holder breaking at the interface between the implant and holder. if an unretrieved device fragment remains threaded into the plate it will not be possible to properly attach the synfix aiming device to the implant (plate). proper attachment of the aiming device to teh plate is required for accurate insertion of the four synfix screws into the synfix implant (plate) and verebral bodies. if the tip holder should break the potential exists for an untretrieved device fragment (urdf) to be left in the synfix-lr implant.