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.This adverse event is being reported after 30 calendar days.This event was original classified under a non-reportable category within the complaint handling system.
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The customer reported an infection on tooth #9 while wearing the aligners.Medical intervention is required, and a root canal will be performed.It is unknown if medical intervention was required.For this event, the patient identifier is (b)(6) and the complaint number is (b)(4).
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