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.Report is for an unknown device/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.
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This report is being filed after the review of the following journal article: el zohairy mm, et al.(2021), treatment of extra articular distal third tibia fracture: plating versus nailing, european journal of molecular & clinical medicine, volume 08, issue 03, page 2774-2783 (egypt).The purpose of this study is to evaluate and compare the operative data and postoperative outcomes between plate fixation, and intramedullary nail technique for identifying proper indications of both methods of fixation.Between january 2015 to december 2019, 96 patients (mean age of 39 years, range 18-60) with distal tibial fractures who had been treated using either minimal invasive plate osteosynthesis technique or expert intramedullary nail technique were included in the study.48 patients were treated with minimal invasive plate osteosynthesis technique using unknown plates while the other 48 patients were treated with an unknown synthes expert tibial nail.Non-weight bearing mobilization was started which progressed to partial weightbearing after 4 weeks at least and full weightbearing was advised once considerable callus was formed.Active range of movements of knee and ankle were initiated as soon as the patient¿s skin condition and pain permitted.Complications were reported as follows: 4 patients had constant pain and stiffness.20 patients had pain while walking on uneven surface.8 patients had constant swelling.24 patients had swelling in the evening.This report is for the unknown synthes expert tibial nail.
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