The manufacturer became aware of a study from department of orthopedic surgery, (b)(6).The title of this study is ¿the first 100 patients treated with a new anatomical pre-contoured locking plate for clavicular midshaft fractures¿ and is associated with the variax clavicle locking plate system.Within that publication, post-operative complications/ adverse events were reported, which occurred between march 2012 and january 2016.It was not possible to ascertain specific device catalogs from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 46 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses asymptomatic nonunion.
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