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 fixture (1002.65a0) is designed as a connecting element for the support and positioning of the patient's head on a maquet or table immediately before during and after surgical interventions as well as for examination and treatment. the fixture is used to adapt a range of different head rests and horseshoe head rests with a central square mount. as part of post market surveillance cases have been reported to maquet gmbh which showed the welded joint between square mount and the first fixable swivel joint broke. this joint must bear the highest loads of all welded joints due to the cantilever. it is likely that the breakage had been caused by a poor welding joint in addition to rough handling and multiple overload by the user respectively. if the weld seam breaks during a procedure a serious injury cannot be ruled out.