The manufacturer became aware of a study from (b)(6).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 patellar tendinitis, bolt removal due to irritation.The study states, ¿in another patient (case 11), the condylar bolt was removed 1 year after fixation because of irritation at the posteromedial insertion site (table i).The same patient had development of patellar tendinitis, achilles tendinitis, and tenderness alongside the peroneal tendons of the ipsilateral leg when he started partial weight-bearing.These symptoms resolved 2 months later with physiotherapy treatment.¿.
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