The manufacturer became aware of a national post-market product surveillance from hospital (b)(6).The title of this report is ¿national post-market product surveillance - tenxor external fixation system¿ which was issued on (b)(6) 2006 and is associated with the tenxor external fixation 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 11 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses septic arthritis of the knee.The post-market product surveillance states: ¿at the 4 weeks assessment, a septic arthritis of the knee was diagnosed during the study [pat.No.17].The treatment of choice was the removal of the material (tenxor and screws).This patient was diagnosed pre-operatively with a complex 41 c 3.1 fracture.At the 12 month postoperative assessment the infection and the fracture was healed completely.¿.
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