510k: this report is for an unknown constructs: lcp/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: chiodini, f.Et al.(2008), fractures of the distal third of the tibia treated by lcp plates and minimally invasive technique: a preliminary report, g.I.O.T., vol.34, pages 121-128 (italy).This prospective study reports the results of the treatment of fractures of the distal third of the leg with lcp plate and minimally invasive plate osteosynthesis (mipo) technique in a consecutive series of patients treated in our division.Between january 2005 and may 2006, a total of 21 patients underwent mipo using an lcp (synthes®, usa).There were 5 females and 16 males with a mean age of 51.5 years (18-70).The following complications were reported as follows: 1 patient manifested asymptomatic pseudoarthrosis of the fibula, leading to breakage of the fibular synthesis device and to its removal.1 patient had excessive prominence of the plate caused its exposure at the distal end.The plate was removed after bone consolidation.2 patients showed greater misalignment than 5 degrees in one of the two radiographic projections, but their aofas score was, anyhow, good (87), and so was the level of satisfaction (91 mm), function (79 mm) and pain (22 mm).2 patients developed a neuroma of the superficial peroneal nerve.Even if their aofas score was low (69-86) and the pain level was high (40-30 mm), the level of satisfaction was high (85-90 mm).The plate was removed with remission of pain in one of these two patients.In five cases the plate was removed after bone consolidation: in two cases due to discomfort determined by the plate during physical exercise, in one case during removal of the fibular plate for the presence of a neuroma on the superficial peroneal nerve, and in one case for distal exposure of the plate.This report is for an unknown synthes lcp.
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