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 peri-implant fracture.The report states, "a (b)(6) caucasian female with a proximal humeral fracture treated with t2 phn showed a periimplant fracture after a fall, 116 days after surgery.The nail was removed, t2 humerus nail was inserted and the patient recovered.(#6)".
|