This report is being filed after the subsequent review of the following literature abstract: balioglu: growing rods and non-fusion treatment for early onset scoliosis (abstracts from the 3rd international congress on early onset scoliosis and growing spine, 20¿21 november 2009, istanbul, turkey), pg 525.This abstract refers to posterior instrumentation and distraction that were applied to 6 patients between 2007 and 2009 (2 juvenile, 4 congenital) with early onset scoliosis (eos) (5 female, 1 male, mean age 7.3; 3.5¿11).A single rod was applied in 1 patient, double rods in 4 patients, veptr in 1 patient.Distraction period was an average of 6 months.Follow-up period was an average of 15.6 (4¿29) months.The average correction was 42% (12¿77) at the final check.Neurological deficit did not develop.This report refers to one patient whose implant loosened but was reinserted.(b)(4).This report is for an unknown veptr, unknown part#/lot#.
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Device was used for treatment, not diagnosis.Balioglu: growing rods and non-fusion treatment for early onset scoliosis (abstracts from the 3rd international congress on early onset scoliosis and growing spine, 20¿21 november 2009, istanbul, turkey), pg 525.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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