The manufacturer became aware of a study from department of orthopedic surgery, bürgerspital solothurn.The title of this study is ¿the first 100 patients treated with a new anatomical pre-contoured locking plate for clavicular mid-shaft 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 reduced rom, infection and revision surgery.1 out of 3 cases.The study states, ¿in three patients, failures occurred due to surgical errors where the medial screws were not placed bi-cortically, with subsequent medial plate loosening.Three patients had a reduced rom in the affected shoulder compared to the non-affected shoulder.One patient with shoulder stiffness which was treated with arthroscopic capsulotomy after 5 and 9 months.In the second arthroscopy, propionibacterium acnes was found and treated with antibiotics and a hardware removal after 1 year showed an implant-associated infection as well.¿.
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