As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The device was not returned for evaluation.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.Additional information has been requested and will be submitted as it becomes available.
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