Device was used for treatment, not diagnosis.Additional narrative konstantinidis, l., et al (2010).Early surgery- related complications after anteroposterior stabilization of vertebral body fractures in the thoracolumbar region.Journal of orthopaedic science, 15, 178-184.This report is for unknown (ventrofix) unknown quantity/unknown lot.Conus - cauda syndrome, compression of spinal cord, partial lesion of left brachial plexus and root disorder.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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Literature article received: this report is being filed after the subsequent review of the following literature article konstantinidis, l., et al (2010).Early surgery- related complications after anteroposterior stabilization of vertebral body fractures in the thoracolumbar region.Journal of orthopaedic science, 15, 178-184.The purpose of this study is to identify typical complications associated with anterioposterior stabilization of vertebral body fractures surgeries.There were 208 patients, average age 41 years, range 15 ¿ 81, 77 female and 131 male.The study was from 2000 ¿ 2006.The procedures were to repair unstable vertebral body fractures of the thoracic or lumbar spine with concomitant rupture of at least one adjacent intervertebral disc.Initial surgical procedures were performed with uss with schanz screws.The second surgery the patients had a non - synthes device or ventrofix.The author did not specify if the complications were related to the non- synthes device or ventrofix.Authors did not specify the complications experienced by male vs.Female patients.Therefore, complications will be reported for both.This report refers to complications for ventrofix: superficial infection, deep infection, hematoma, pleural effusion, pneumothorax, total paraplegia, paraparesis, conus - cauda syndrome, compression of spinal canal, partial lesion of left brachial plexus, root disorder and revision surgeries.This is report 6 of 6 for (b)(4).This report is for a unknown ventrofix.Complications for male patients.A copy of the literature article is being submitted with this medwatch.
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