The manufacturer became aware of a study from (b)(6).The study was published on july 2017, within that publication, 11 cases involving t2 ankle arthrodesis nail, or t2 tibial nail were reported, which were found to be off-label.The study states, ¿the purpose of this study was to present a case series of patients undergoing various techniques of joint fusion after bone reconstruction and deformity correction as a salvage procedure.The study should help trauma surgeons making decisions in limb salvage and deformity correction in complex lower leg and foot injuries by presenting options and treatment strategies.¿ it was not possible to ascertain specific device from the report, a review of the complaint handling database, however, revealed that the events have not been reported previously, therefore 11 complaints were initiated retrospectively for the off-label use and subsequent adverse events mentioned in the report.This product inquiry addresses superficial wound infection or delayed wound healing.2 out of 3 cases.
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