"pmcf)" from (b)(6).The title of this report is ¿a post-market clinical follow-up (pmcf) of the treatment of femoral fractures with the t2 nailing systems¿ which was published in november 2018 and is associated with the t2 femoral nailing system (t2 femur a/r).Within that publication, post-operative complications/ adverse events were reported, which occurred between november 2012 to september 2017.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, 55 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses pulmonary embolism.2 out of 2 cases.
|