The current instructions for use (ifu) contains the following: "precautions - a tooth that has been previously traumatized or significantly restored may be aggravated.In rare instances, the useful life of the tooth may be reduced, the tooth may require additional dental treatment such as endodontic and/or additional restorative work, and/or the tooth may be lost"; and "the health of the bone and gums which support the teeth may be impaired or aggravated"; and "the length of the roots of the teeth may be shortened during orthodontic treatment, which may become a threat to the longevity of the teeth." the treating doctor shared that he is not sure if the event was due to the aligner because he did not see the patient for a long time (due to covid-19 emergency), but confirmed that the event was not due to any pre-existing condition or periodontal issues.Thus, there is no conclusive evidence that has been provided that supports or opposes the fact that the invisalign system aligners caused or contributed to the reported symptom of tooth loss.This event is being filed as an mdr as the patient reported tooth loss (serious injury) and the invisalign system aligners were being used.
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