SMILE DIRECT CLUB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-27 for SMILE DIRECT CLUB manufactured by Align Technology Inc..

Event Text Entries

[176811416] Pt was using aligners from (b)(6) and she had been left with posterior open bite and teeth only contacting on the anterior which was causing her teeth to chip. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092556
MDR Report Key9637145
Date Received2020-01-27
Date of Report2020-01-24
Date of Event2020-01-15
Date Added to Maude2020-01-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSMILE DIRECT CLUB
Generic NameALIGNER, SEQUENTIAL
Product CodeNXC
Date Received2020-01-27
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerALIGN TECHNOLOGY INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-27

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