This report is for an unknown plate and screw construct/unknown lot.Part and lot number 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.(b)(4).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.(b)(4).
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This report is being filed after the review of the following journal article: kamrani, r.S., farhoud, a.R., nabian, m.H., and farhadi, l.(2015), treatment of nonunion of forearm bones using radial forearm bone flap, trauma monthly, vol.20 (4), pages 1-7 (iran).The aim of this prospective study is to evaluate the medium-term effects of the radial forearm bone graft technique in cases with forearm nonunion.Between october 2007 to december 2013, a total of 7 patients (2 male and 5 female) with a mean age of 41.3 years (range: 20-72 years) were included in the study.Initial treatment consisted of internal fixation with plates and screws in all patient, using lcdcp in 1 patient.Nonunion site of the radius or ulna was performed via radial forearm bone flap and internal plate fixation, where the nonunion site was bridged by a new locking plate (lcp) if the previous hardware was insufficient, broken or absent.The mean duration of follow-up was 34 (range: 7-80) months.The following complications were reported: case 7: a (b)(6) year old female patient who was initially treated with lcdcp had a forearm nonunion.She had a hypoesthesia in superficial radial nerve area after the procedure.Case 2: a (b)(6) year old female patient had hypoesthesia in the superficial radial nerve area.Case 4: a (b)(6) year old female patient had transient pain at the donor site of the radius for 7 months.This report is for an unknown synthes plate/screws constructs.This is report 1 of 3 for (b)(4).
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