This report is being filed after subsequent review of the following abstract: smith, j.And smith, m.Treatment of progressive spinal deformity using the veptr device with a bilateral percutaneous rib to pelvis technique in non-ambulatory children with neuromuscular disease.The 2nd international congress on early onset scoliosis and growing spine, november 7¿8, 2008.Pg 162.Usa article.This article retrospectively reviewed 11 children with progressive scoliosis or kyphosis associated with neuromuscular disease treated with the bilateral percutaneous rib to pelvis technique.The diagnosis was varied (spina bifida 5;myopathy/sma3;cerebral palsy 1; unclassified syndromes 2) all were non-ambulators and wheelchair dependent.Eight patients had scoliosis, 2 had kyphosis, and one had lordosis.The average age at the time of index surgery was 76 months (range 22¿131 mo) and the average length of follow up was 24.3 months.For the scoliosis group, there was improvement in the average pre-op coronal cobb angle from 65 degrees to 47 degrees.The sagittal cobb angle improved from 53 to 31 degrees.For the sagittal deformity group (3), the average pre-op sagittal cobb was 116 degrees and improved to 64 degrees at an average follow-up of 32 months.Adverse events were uncommon and easily managed (pelvic migration 1, rib cradle migration 8 in 4 patients, wound dehiscence 5 in 2 patients).This report refers to complications reported in unspecified patients: wound dehiscence 5 in 2 patients.This is report 2 of 2 for (b)(4).This report is for an unknown veptr, unknown part#/lot# and unknown quantity.
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Device was used for treatment, not diagnosis.Treatment of progressive spinal deformity using the veptr device with a bilateral percutaneous rib to pelvis technique in non-ambulatory children with neuromuscular disease.The 2nd international congress on early onset scoliosis and growing spine, november 7¿8, 2008.Pg 162.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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