The manufacturer became aware of a post-market product surveillance from (b)(6).The title of this report is ¿international multicentre post-market product surveillance - t2 humeral nailing system antegrade vs.Retrograde approach¿ which was issues on 10/31/2004 and is associated with the t2 humeral 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 12 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses non-union, distal locking of the nail performed on (b)(6) 2001.The 1 out of 3 cases.The report states: ¿non-union was documented in three cases (5.4%).In one case only distal locking of the nail was performed to solve the problem.¿.
|