This report is for two (2) unknown vertical expandable prosthetic titanium rib (veptr) rods.Part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 subsequent review of the following literature article: konieczny (2017) vertical expandable prosthetic titanium ribs (veptr) in early-onset scoliosis: impact on thoracic compliance and sagittal balance.Journal of children's orthopaedics.Volume 11, pages 42-48.Germany.The aim of our study was to investigate the impact of scoliosis on thoracic compliance and also to analyze the quality of deformity correction in the coronial plane and the impact of veptr on sagittal balance (sagittal plane).This article is a retrospective review of a study conducted between 2004 to 2011 in which 21 consecutive children treated with vertical expandable prosthetic titanium ribs (veptr) were analyzed.The mean age at initial surgery was 5.26 years.After initial surgery, these patients had elongation procedures every six months.Follow-up was 60.67 months.The following complications were recorded: 5 patients sustained mechanical complications: three rib¿anchor dislocations, one lamina hook dislocation and two rod breakages.3 patients sustained soft-tissue complications from implant-related ulcers.Two patients could be managed by local revision and one patient received defect repair by a local musculocutaneous flap.A copy of the literature article is being submitted with this medwatch.This report is for two (2) unknown vertical expandable prosthetic titanium rib (veptr) rods.This is report 3 of 4 for complaint (b)(4).
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