Model Number INVISALIGN SYSTEM - COMPREHENSIVE |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Code Available (3191)
|
Event Date 12/01/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
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 the symptom a tooth extraction (permanent impairment to a body structure) and an align product was being used.
|
|
Event Description
|
The patient reported having teeth extracted (unspecified teeth).It is unknown if the patient required any medical intervention.It is unknown if the patient took or was prescribed any medication due to the extraction.It is unknown if the treatment has been discontinued or if the patient is still wearing the aligners.
|
|
Search Alerts/Recalls
|