Based on the information provided by the patient, there is no conclusive evidence that supports or opposes the fact that the aligners caused, contributed, or would likely cause or contribute to the reported event.This event is being filed as an mdr since the patient reported symptoms or physiological conditions related to a tooth infection that resulted in a loss of a tooth.As per capa # (b)(4) this event is retrospectively being reported and therefore was not reported within the required 30-days.
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