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 9/19/2006 and is associated with the tenxor external fixation system.Within that report, postoperative 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 infection.One out of 6.The post-market product surveillance states: ¿at the six months assessment, one patient showed a rotational deformity of the foot after the treatment of his distal tibia fracture.The tenxor¿ system was removed and the patient was treated with an ankle arthrodesis [pat.No.2].¿.
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