This report is being filed after subsequent review of the following article: samdani (april 2009): bilateral use of the vertical expandable prosthetic titanium rib attached to the pelvis: a novel treatment for scoliosis in the growing spine.J.Neurosurg spine, vol 10, 287-292.Usa.In this article the authors report their experience with using bilateral veptrs from the ribs to the pelvis for children with severe, early onset scoliosis.Eleven children (7 female, 4 male, avg age: 71 months) were identified who had been treated with bilateral veptrs from the ribs to the pelvis.The authors conducted a retrospective review and collected the following data: clinical diagnosis, age at surgery, number of lengthening procedures, and complications.In addition, pre- and postoperative radiographs were reviewed to measure maximum cobb angle (both thoracic and lumbar), thoracic height, total spine height as measured from t-1 to s-1, thoracic kyphosis (t2¿12), and lumbar lordosis (l1¿s1).There were no neurological, vascular, or visceral complications in these patients.Four of the 11 patients experienced a total of 6 other complications.Migration of pelvic hooks in 3 patients and erosion of superior cradles through the ribs in 1 patient.Both the hooks and the cradles were reattached during a routine lengthening procedure.This is report 1 of 3 for (b)(4).This report is for an unknown veptr, unknown part#/lot# and unknown quantity.
|
Device was used for treatment, not diagnosis.This report is for unknown veptr/unknown quantity/unknown lot.(b)(4).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.
|