The manufacturer became aware of a study from "evangelismos" general hospital, athens, greece.The study was published on 26 jun 2017, within that publication, 17 cases involving t2 tibial nail & condylar bolts were reported, which were found to be off-label.The study states, ¿the present report describes the short and intermediate term results of treatment of bicondylar tibial plateau fractures with use of this new technique.The treatment of bicondylar fractures of the tibial plateau with intramedullary nailing and a condylar bolt or bolts via the suprapatellar approach requires good experience with intramedullary nailing.Therefore, adequate training is required before the adoption of this technique.¿ 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 17 complaints were initiated retrospectively for the off-label use mentioned in the report.This product inquiry addresses refixation due to unsatisfactory reduction of the articular surface.The study states, ¿in 1 patient (case 8), refixation of the fracture was necessary because of unsatisfactory reduction of the articular surface, as shown on radiographs made 5 days after the initial operation.¿.
|