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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Skin Erosion (2075); Impaired Healing (2378)
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Event Type
Injury
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Event Description
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This report is being filed after the subsequent review of the following literature abstract: latalski: difficulties in the treatment of early onset scoliosis with the usage of veptr (abstracts from the 3rd international congress on early onset scoliosis and growing spine, 20¿21 november 2009, istanbul, turkey), pg 528.The aim of the authors was to evaluate the difficulties of surgical treatment using the vertical expandable prosthetic titanium rib (veptr) system.About 13 pts (38 procedures) treated with the use of veptr in the children orthopedic department of the medical university of lublin, poland.Three due to widely spread congenital malformation of the spine), 5 due to progressing neuro-mascular scoliosis, 5 are under treatment due to kyphosis resulting from myelomeningocele.The number of surgeries varies with each child and ranges from 2 to 6.The follow-up ranges from 6 month to 2.5 year.Complications reported: rib fracture, chest wall scarring, rib fusions beneath devices.(b)(4).This report is for an unknown veptr, unknown part#/lot#.
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Latalski: difficulties in the treatment of early onset scoliosis with the usage of veptr (abstracts from the 3rd international congress on early onset scoliosis and growing spine, 20¿21 november 2009, istanbul, turkey), pg 528.This report is for unknown veptr/unknown quantity/unknown lot.(b)(6).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was 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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Search Alerts/Recalls
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