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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Due to a manufacturing error in lot l33 the gripping jaws are not sufficiently flexible to disconnect easily from the intended cervical sleeves. gm11000960 cervical sleeves 40mm with clamp for guide tube gm11001260 cervical sleeves 60mm with clamp for guide tube gm11001140 cervical sleeves 80mm with clamp for guide tube. if an affected guide tube is connected to an implanted cervical sleeve disconnection will be difficult. if removal is attempted with sufficient force to tear the anchoring sutures it is possible that the patient will be injured. the issue is limitated to devices with the manufacturing lot 33.