Device was used for treatment not diagnosis.Additional narrative: (b)(4).This report is for unknown vertical expandable prosthetic titanium rib (veptr) system.Investigation could not be completed and no conclusion could be drawn, as no devices were returned and no lot numbers or part numbers were 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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This report is being filed after the subsequent review of the following journal article: waldhausen, j., redding, g., white, k., song, k.(2016) complications in using the vertical expandable prosthetic titanium rib (veptr) in children.Journal of pediatric surgery, vol.51, pp: 1747-1750.This report describes complications using the vertical expandable prosthetic titanium rib (veptr, depuy synthes,(b)(4)) for thoracic insufficiency syndrome (tis).Thirty five (35) patients with veptr i implants and 30 patients with veptr ii implants were included in this study between october 2001 and november 2014.The average age at implantation was 6.9 years (range 1.3¿24.8 years) with an average follow up of 6.9 years (range 0.4¿14.8 years).Three patients had implant fracture, 1 from the veptr itself and 2 from the intramedullary wire placement (4.6%) used in our early patients to provide extra rigidity to the chest wall.This report is for an unknown vertical expandable prosthetic titanium rib (veptr) system.This is report 3 of 3 for (b)(4).
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