The manufacturer became aware of a study from department of trauma & orthopaedics, altnagelvin hospital, northern ireland, uk.The title of this study is ¿pre-requisites for optimum centering of a tibiotalocalcaneal arthrodesis nail¿ and is associated with the t2 ankle arthrodesis nail.The study published in may 2014 reported post-operative complications/ adverse events.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, 9 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses locking screws backed out.2 out of 2 cases.The study states: "patient required removal of both proximal tibial locking screws and the postero-anterior calcaneal screw for ongoing pain at these sites, despite the screw heads not being palpable.¿.
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