The manufacturer became aware of a study from department of orthopaedics, (b)(6) general hospital, (b)(6) which was published in september 2015.The title of this study is ¿retrograde intramedullary tibiotalocalcaneal (hindfoot) arthrodesis with concomitant midfoot and forefoot corrections¿ and is associated with the stryker t2 ankle arthrodesis nailing system.Within that publication, post-operative complications/ adverse events were reported, which occurred between may 2009 and may 2013.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, 10 complaint was initiated retrospectively for the different adverse event mentioned in the report.This product inquiry addresses an infected talus screw.The study states that, ¿(b)(6) male, charcot arthropathy, medial approach for severe valgus hindfoot deformity, concomitant procedure: talectomy, midfoot osteotomy infected talus screw, nonunion tibiotalar joint.Removal of locking screw: same patient (above line) as nonunion, infected screw.¿.
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