Model Number INVISALIGN SYSTEM - COMPREHENSIVE |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Code Available (3191)
|
Event Date 01/01/2019 |
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 tooth extraction (permanent impairment to a body structure) while an align product was being used.
|
|
Event Description
|
The patient reported symptoms of soreness of tooth #14 (upper left 1st molar).The patient reported having tooth # 14 extracted due to the pain.The patient reported being prescribed painkillers (unspecified) and antibiotics (unspecified) to alleviate the reported symptoms.The treatment was discontinued on (b)(6) 2019 and the patient is currently asymptomatic.
|
|
Search Alerts/Recalls
|