The current instructions for use (ifu) contains the following: "general risks to patients - health of the bone and gums which support the teeth may be impaired or aggravated" and "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".The potential root cause of this event is unknown.No conclusive evidence has been provided that supports or opposes the fact that the invisalign retainers caused or contributed to the reported symptoms of tooth loss (anticipated) and the need for implants (scheduled next month).This event is being filed as an mdr as the patient reported anticipated tooth loss (serious injury) and an invisalign product was being used.
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