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 infection.
|
The customer reported infection while wearing the aligners.Medical intervention is required, a root canal was performed and a permanent crown will be placed.The treatment was discontinued.For this event, the patient identifier is (b)(6) and the complaint number is (b)(4).
|