This report is for an unknown plates: lcp medial distal tibial plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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This report is being filed after the review of the following journal article: villamil gallego et al (2015) fractures of the distal tibia treated with angular stability plates.Retrospective observational study of open and minimally invasive techniques, rev pie tobillo.Volume 29(1): pages 11-16 (spain).This retrospective study aims to provide a retrospective analysis of fractures of the proximal third of the intra-articular distal tibia, classified according to the ao as 43b and 43c, treated with angular stable plates.A comparison is made of the outcome of open versus minimally invasive techniques.Between june 2000 and june 2012, 21 patients (6 females, 15 males) with a mean age of 49 years (22-77) diagnosed with fractures of the distal end of the tibia were retrospectively reviewed and analyzed.Patients were treated surgically with angular stable plates, namely lcp medial distal tibial plate, depuy synthes companies of johnson and johnson, and with a follow-up equal to or greater than 12 months.5 patients underwent minimally invasive technique and 16 underwent open technique.Mean follow-up was 27 months.The following complications were reported as follows: initial complications of the minimally invasive technique: superficial infection 2 patients.Skin necrosis 2 patients.Blisters 1 patient.Reintervention 1 patient.Minimally invasive technique late complications: post-traumatic osteoarthritis 2 patients.Residual pain 2 patients.Reintervention 2 patients.Osteomyelitis 1 patient.Initial complications open technique: blisters 5 patients.Skin necrosis 4 patients.Superficial infection 2 patients.Reintervention 2 patients.Late complications open technique: pain 4 patients.Pseudarthrosis 3 patients.Reintervention 3 patients.Vicious consolidation 1 patient.Post-traumatic osteoarthritis 1 patients.This report is for an unknown synthes angular stable plates, namely lcp medial distal tibial plate.
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