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 212 complaints were initiated retrospectively for different adverse events mentioned in the report.The 23 patients developed early post-operative complications within the first week (day 1 to day 8).This product inquiry addresses intramedullary guide wire not be introduced in to the i.M.Canal of distal tibia.Reaming with 8mm drill wire.Histopathology of case material.
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