This product inquiry addresses deep infection.The pmcfr states: ¿a patient was found to have deep infection of the implanted hardware; underwent irrigation and debridement of the surgical wound and had positive cultures for bacillus species, an anaerobic bacteria species.This infection resolved following surgical irrigation and debridement and intravenous antibiotics.¿ the manufacturer became aware of a post market clinical follow-up report (pmcfr) 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 greater trochanter entry femoral nailing system (gtn) which was published in june 2018 and is associated with the t2 greater trochanter entry femoral nailing system (gtn).Within that publication 3 adverse events were reported, which occurred between 2012 to 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 had not been reported by the hospital or by the author of the publication, therefore 3 complaints were initiated retrospectively.All 3 adverse events involved static mode 1.All 3 adverse events took place on the right side.
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