This report is being filed after the subsequent review of the following journal article: lu, c.-c.Et al (2014) complications and technical pitfalls of titanium elastic nail fixation for midclavicular fractures.Orthopedics 37(4), e377-e383.From january 2007 to april 2008, 27 patients (17 men, 10 women; mean age 45.8 years; range 16.5-66.9 years) with marked displaced midclavicular fractures underwent fixation with titanium elastic nails (synthes, (b)(4)).No infection, nonunion, nail dislocation, or implant breakage occurred and all procedures healed without secondary procedures.One patient experienced severe tip prominence/protrusion and bone shortening that required implant removal.This is report 4 of 4 for (b)(4).This complaint is for an unknown titanium elastic nail.This report is for 1 devices.
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Device was used for treatment, not diagnosis lu, c.-c.Et al (2014) complications and technical pitfalls of titanium elastic nail fixation for midclavicular fractures.Orthopedics 37(4), e377-e383.This report is for an unknown titanium elastic nail.(b)(4).Bone shortening.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.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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