This report is for an unk - constructs: tomofix plate/ screws/ 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: kim, m.S.Et al.(2021), alignment adjustment using the valgus stress technique can increase the surgical accuracy of novice surgeons during medial opening-wedge high tibial osteotomy, bmc musculoskeletal disorders, vol.22:585, pages 1-11 (south korea).The purpose of this study was to compare the degree of accuracy of coronal alignment correction with the use of the ¿alignment adjustment under valgus stress technique¿ between expert and novice surgeons during medial opening-wedge high tibial osteotomy (mowhto).From june 2018 to november 2019, a total of 77 patients underwent mowhto.There were 63 females and 14 males.The osteotomy site was fixed with a locking plate (tomofix; synthes, solothurn, switzerland).The following complications were reported as follows: 17 cases had hinge fractures.A fixed rehabilitation protocol that allowed weight bearing at 4 weeks after surgery was applied to patients with lateral hinge fractures.This report is for an unknown synthes tomofix.This report is for one (1) unk - constructs: tomofix plate/screws.This is report 1 of 1 for complaint (b)(4).
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