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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment not diagnosis.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 is for unknown vertical expandable prosthetic titanium rib (veptr) system.(other number) udi: unknown part number, udi is unavailable.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.(b)(4).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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Event Description
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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).Nine patients (13.8%) had wound infections though only 1 (1.5%) of these was related to the primary implantation.The 8 others (12.3%) were in individual patients occurring in reoperative wounds used for veptr expansion or replacement.All of these were culture positive for skin flora and 2 required implant removal.Two of the children with veptr chest wall reconstructions developed progressive scoliosis and needed fusion.This report is for an unknown vertical expandable prosthetic titanium rib (veptr) system.This is report 2 of 3 for (b)(4).
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Search Alerts/Recalls
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