The manufacturer became aware of a 'retrospective data collection report' from (b)(6).The title of this study is ¿a retrospective data collection of the treatment of humeral fractures with the t2 proximal humeral nailing system (phn)¿ and is associated with the t2 proximal humeral nailing system (phn).Within that publication, post-operative complications/ adverse events were reported, which occurred between 2012 to 2017.It was not possible to ascertain specific device catalogs from the report, 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 30 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses lag screw protrusion (cut out); 11 out of 13 cases.The report states, "a (b)(6) caucasian female (#61) has two adverse events.She showed necrosis of head of humerus with cut out of proximal screws.48 days after surgery the implant was removed and endoprosthesis inserted.The fracture was not consolidated prior to removal of implant." this pi refers to "cut out of proximal screws.48 days after surgery the implant was removed".
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