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); 9 out of 13 cases.The report states, "a (b)(6) caucasian female (#55) suffered two adverse events.She showed necrosis of the head of the humerus with cut out of all proximal screws.67 days after surgery the nail was removed.The fracture was not consolidated prior to removal of implant.This patient received conservative treatment with gilchrist bandage and careful training." this pi is for cut out of all proximal screw and removal of the nail.
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