Based on the information provided by the patient and internal investigation conducted by access dental lab, 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 that describe tooth fracture, followed by tooth infection, which resulted in necrosis of the tooth.
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The customer reported that a tooth broke while wearing the aligners, followed by infection of the tooth that resulted in tooth necrosis.The customer required medical intervention; a root canal and restorative work was performed.As a result, aligner treatment was discontinued.
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