As a result of this malfunction, the potential for surgical intervention exists to preclude injury or illness that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.This event, therefore, is reportable per 21cfr part 803.This report is for the seventh device.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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