This report is for an unknown lcp superior clavicle plate/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.(b)(4).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: kim, h.Y.Et al.(2020), clinical and radiological outcomes after various treatments of midshaft clavicle fractures in adolescents, clinics in orthopedic surgery, vol.12, pages 396-403 (south korea) https://doi.Org/10.4055/cios20026.The purpose of this study was to compare the clinical and radiological outcomes of 4 different treatments for midshaft clavicle fractures in adolescents: conservative treatment with a figure-of-8 (fo8) brace, open reduction and internal fixation with a plate (opl), minimally invasive plate osteosynthesis (mipo), and intramedullary nail fixation with a threaded steinmann pin (tsp).From 2010 to 2015, a total of 49 patients with midshaft clavicle fractures underwent fixation using the lcp superior clavicle plate (depuy synthes, oberdorf, switzerland) and precontoured locking plate (acumed, hillsboro, or, usa).The article did not specify which of the devices were being used to capture the following complications: 7 patients had metal-induced irritating symptoms.2 patients had superficial skin infections.They were treated with antibiotics therapy without a surgical procedure.1 patient had supraclavicular nerve injury symptoms at the final follow-up.4 patients had refractures after plate removal.Three fractures were caused by another trauma at >3 months after metal removal.However, 1 refracture occurred within 6 weeks after plate removal.This report is for an unknown synthes lcp superior clavicle plate.This is report 1 of 1 for (b)(4).
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