ALIGNERS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for ALIGNERS manufactured by Smile Direct Club / Align Technology, Inc..

Event Text Entries

[181381998] Sdc aligners were not fitting and were causing tmj problems. The only help i am getting is to keep going it will get better. Well it hasn't. My teeth have not straightened and i have no bite. It is hard to chew as my jaw hurts. I have gotten 2 sets of aligners but there is no difference. This online orthodontist is a scam and i am angry i fell for it. This dentist must stop. I am going to see a real orthodontist in person as something has to be done to correct this mess. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093287
MDR Report Key9753845
Date Received2020-02-25
Date of Report2020-02-22
Date of Event2019-09-01
Date Added to Maude2020-02-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALIGNERS
Generic NameALIGNER, SEQUENTIAL
Product CodeNXC
Date Received2020-02-25
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-25

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