ALIGN TECHNOLOGY, INC. INVISALIGN RETAINER; VIVERA RETAINER; MAINTAINER, SPACE PREFORMED, ORTHODONTIC
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Model Number INVISALIGN RETAINER |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Tooth Fracture (2428)
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Event Date 06/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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The current instructions for use (ifu) contains the following: "general risks to patients -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 "health of the bone and gums which support the teeth may be impaired or aggravated." the potential root cause is unknown.No conclusive evidence has been provided that supports or opposes the fact that the invisalign retainers caused the reported symptom of tooth extraction.This event is being filed as an mdr as the patient reported tooth loss (serious injury) and the invisalign retainers were being used.This event was reported by the patient (initial reporter).
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Event Description
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The patient reported that bone was infected due to cracked root, and ended up needing a bone graft, extraction and implant (tooth # unspecified).It is unknown if the patient required any medical intervention to alleviate the reported symptoms.It is unknown if the patient took or was prescribed any medication to alleviate the reported symptoms.It is unknown if the patient is still wearing the retainers.
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Search Alerts/Recalls
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