Literature articled received.This report is being filed after subsequent review of the following literature article: gauthier, l, et al (2014).Perioperative neurologic injury associated with rib-based distraction surgery.Spine deformity, 2, 481-488.(b)(4).There was a retrospective review of the children¿s spine study group database from 2004-2013.The researchers used the chi-squared test to compare the distributions of portions between diagnoses.The inclusion criteria were any rib-to-rib or spine-to-rib instrumentation.Growing rods without rib based attachments were excluded.A total of 524 patients were identified who were treated with rib-based distraction surgery.Nine neurologic injuries were identified in these patients (7 clinical and 2 neuro-monitoring alerts) for a neurologic injury rate of 1.7%.Using the classification for early-onset scoliosis, 8 patients were classified as congenital and 1 as neuromuscular.At the time of injury, the mean age was 4.1 +/- 2.2 years, the mean scoliosis was 66.3° +/- 21.9°, and the mean kyphosis was 43.5° +/- 36.9°.All of the injuries occurred at the time of initial implantation, with the exception of 1 patient in whom injury occurred during revision surgery.There were no injuries identified during routine lengthening surgery.There were no complete spinal cord injuries and most involved injury to the brachial plexus.Two patients counted as having a neurologic injury had changes in neuromonitoring only but no deficits existed on post-operative clinical exams.Of the other 7 with clinical injuries, only 2 had a neuromonitoring alert.Four patients required return to surgery and 1 needed intraoperative intervention.At the 4.2 years¿ follow-up, 7 of 9 patients had full resolution of symptoms and 2 patients had residual upper extremity weakness.This report refers to patient # 4.Patient 4 was 1 years, 4 months at the time of the event.Their primary diagnosis was congenital scoliosis with fused ribs with a secondary diagnosis of syrinx.Their construct levels were medial ~t2/3/t4-t9, 10.Patient 4 experienced mild brachial plexus injury ipsilateral.The cause of this is injury is listed as unknown.The course of action was observation and they recovered from their injury.This is report 4 of 9 for (b)(4).This report is for an unknown vertical expandable prosthetic titanium rib (veptr) construct, unknown part#/lot#.A copy of the literature article is being submitted with this medwatch.
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Gauthier, l, et al (2014).Perioperative neurologic injury associated with rib-based distraction surgery.Spine deformity, 2, 481-488.This report is for an unknown veptr/unknown quantity/unknown lot.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number for 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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