This report is being filed after the subsequent review of the following literature article: campbell, r.M., et al (2007).The effect of mid-thoracic veptr opening wedge thoracostomy on cervical tilt associated with congenital thoracic scoliosis in patients with thoracic insufficiency syndrome.Spine, volume 32, number 20, pp 2171-2177.Usa article.The purpose of the study was to report the efficacy and safety of veptr mi-thoracic opening wedge thoracostomy in treatment of cervical tilt and head/truncal decompensation in children with thoracic insufficiency syndrome associated with thoracic congenital scoliosis.The study included: 14 patients (6 females, 8 males), mean age at time of surgery 4.4 years (ranging 1.8-12.5 years), mean follow-up time was 3.4 years (ranging 2-5.75 years), and the patients had the following co-morbidities: congenital renal abnormalities, congenital heart disease, asthma, and spinal cord abnormalities.Two patients had spinal fusions before veptr treatment.Four patients had tether release before veptr.Most patients had a unilateral hybrid rib-to spine veptr and rib-to rib veptr; 3 patients had bilateral veptr construct.Multiple radiographs were taken pre-operatively and post-operatively as well as ct scans and mris.Complications: asymptomatic posterior/inferior spinal hook migration occurred (n=4), averaging 3.25 years to complete dislodgement, and they were reseated at the time of scheduled expansion procedures.This report is for an unknown veptr with unknown part and lot numbers and quantity.This is report 4 of 5 for (b)(4).
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Device was used for treatment, not diagnosis.Literature citation: campbell, r.M., et al (2007).The effect of mid-thoracic veptr opening wedge thoracostomy on cervical tilt associated with congenital thoracic scoliosis in patients with thoracic insufficiency syndrome.Spine, volume 32, number 20, pp 2171-2177.This report is for an unknown veptr with unknown part and lot numbers.(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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