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 the potential root cause of this event could have that the cervical resorption possibly has gotten worse with aligners.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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