The current instructions for use (ifu) contains the following: "precautions - existing dental restorations (e.G: crowns, bridges) may become dislodged and require re-cementation or, in some instances, replacement," "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 health of the bone and gums which support the teeth may be impaired and aggravated," and "gums, cheeks, or lips may be scratched or irritated by the product." the potential root cause is unknown.No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused the reported symptom.This event is being filed as an mdr as the patient reported tooth loss (serious injury) and the invisalign product was being used.
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The patient reported symptoms of extraction of lower anterior teeth and recessions.The patient reported requiring medical intervention like bone grafting and implant placement to alleviate the reported symptoms.The patient reported being prescribed amoxicillin, norco, motrin and medrol dose pack to alleviate the reported symptoms.The treatment was discontinued on (b)(6) 2022 and the patient is currently getting better.
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