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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The indications on the current version of the synfix lr system package insert differ from the indications approved by health canada on licence #77494. the package insert contains labelling that indicates it is approved for vertebral body replacement (vbr). this is not an approved indication for use in canada. the approved indications for use in canada are for interbody fusion (ibf).
Model Catalog: 08.802.019S (Lot serial: ALL LOTS); Model Catalog: 08.802.016S (Lot serial: ALL LOTS); Model Catalog: 08.802.015S (Lot serial: ALL LOTS); Model Catalog: 08.802.014S (Lot serial: ALL LOTS); Model Catalog: 08.802.013S (Lot serial: ALL LOTS); Model Catalog: 08.802.012S (Lot serial: ALL LOTS); Model Catalog: 08.802.011S (Lot serial: ALL LOTS); Model Catalog: 08.802.010S (Lot serial: ALL LOTS); Model Catalog: 08.802.009S (Lot serial: ALL LOTS); Model Catalog: 08.802.008S (Lot serial: ALL LOTS); Model Catalog: 08.802.007S (Lot serial: ALL LOTS); Model Catalog: 08.802.006S (Lot serial: ALL LOTS); Model Catalog: 08.802.005S (Lot serial: ALL LOTS); Model Catalog: 08.802.004S (Lot serial: ALL LOTS); Model Catalog: 08.802.003S (Lot serial: ALL LOTS); Model Catalog: 08.802.002S (Lot serial: ALL LOTS); Model Catalog: 08.802.000S (Lot serial: ALL LOTS); Model Catalog: 08.802.001S (Lot serial: ALL LOTS); Model Catalog: 08.802.018S (Lot serial: ALL LOTS); Model Catalog: 08.802.017S (Lot serial: ALL LOTS); Mod