The manufacturer became aware of a international post-market product surveillance from (b)(6).The title of this report is ¿international post-market product surveillance - t2 tibial nailing systems¿ which was released on 10/31/2005 and is associated with the t2 tibial nailing system.Within that report, intraoperative and post-operative complications/ adverse events were reported.It was not possible to ascertain specific device or patient information from the article, 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 211 complaints were initiated retrospectively for different adverse events mentioned in the report.Post-operative complications were present at 12 months assessment.This product inquiry addresses proximal screw loosening with proximal nail migration.The nail was relocated.
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