Model Number INVISALIGN FULL ADDITIONAL ALIGNERS |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Code Available (3191)
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Event Date 01/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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No conclusive evidence has been provided that supports or opposes that fact that the invisalign system aligners caused or contributed to the patients symptoms.This event is being filed as an mdr as the patient reported loosing tooth # 29 (permanent impairment to a body structure) while an align product was being used.
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Event Description
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The patient reported symptoms of tooth mobility on # 29 (lower right 2nd premolar), and loss of tooth # 18 (lower left 2nd molar).The patient did not report requiring any medical intervention to alleviate the reported symptoms.The patient did not report taking or being prescribed any medication to alleviate the reported symptoms.The treatment has not been discontinued as the patient is still wearing the aligners.
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Search Alerts/Recalls
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