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 potential root cause of this event is unknown.After reviewing available records (scan, photos, and x-rays) and per align's clinical assessment, the tooth #2.7 appeared to be considerably restored (almost the entire crown).Tooth #2.7 had a large resin with lack of anatomy, root canal treatment and possible tooth structure damage underneath.The mentioned clinical condition indicates a poor prognosis of the molar (#2.7).No conclusive evidence 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.Note: due to the limited available information about this event, the date of the event is estimated to have occurred around 11/15/2023 (based on manufacturing date, delivery of aligners, and when the event was reported to align), as indicated in field b3; however, no conclusive evidence has been provided to confirm.
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