The manufacturer became aware of a study from ¿university hospital (b)(6)¿ which was published in january 2011.The title of this study is ¿short-term outcome of retrograde tibiotalocalcaneal arthrodesis with a curved intramedullary nail¿ and is associated with the t2 ankle arthrodesis nail.Within that publication, post-operative complications/ adverse events were reported which occurred between march 2005 and april 2008.It was not possible to ascertain specific device details from the report; a review of the complaint handling database, however, revealed that the event has not been reported by the hospital or by the author of the publication.Therefore, 23 complaint were initiated retrospectively for the different adverse event mentioned in the report.This product inquiry addresses soft-tissue irritation.1 out of 3 cases.The study states: ¿in three cases the nail had caused soft-tissue irritation.Once sound union had been ascertained, the calcaneal screw was removed in two of these patients, while in the third patient the entire nail was removed.¿.
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