This report is being filled after the subsequent review of the following journal article "halo-gravity traction versus surgical release before implantation of expandable spinal devices".An observational study of 124 patients with severe early-onset spinal deformity were treated with the vertical expandable prosthetic titanium rib or growing rods.Of the 124 patients, 96 patients had all the radiographic data required for the study.Before implantation of the device of the 96 patients; 12 underwent halo-gravity traction (hgt), 13 had a spinal release (sr) and 71 controls did not undergo any preliminary hgt or sr treatment.This study is based on x-rays obtained before and after surgery and at the last follow-up and on medical records.The thoracic scoliosis and kyphosis, and the thoracic height and spinal length was measured on the x-rays.Post-operative complications were also collected.Device loosening occurred in the 34 participants, 20 in the control group, 7 in the halo traction group and 9 in the surgical release group.Device loosening had a negative impact on the final thoracic spine height.This is 1 of 3 report for (b)(4).Report for unknown veptr.
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Device was used for treatment, not diagnosis.Mean age 5.77 years.Mean age for 96 patients that had all x-rays required for the study.Total 96 patients- 49 female & 47 male.Article published; april 2011.Exact date unknown.This report for unknown veptr, unknown part#/lot#.Jean-francois et al (2011, april).Halo-gravity traction versus surgical release before implantation of expandable spinal devices.A comparison of results and complications in early-onset spinal deformity.J.Spinal disorder tech, volume 24, number 2, 99-104.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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