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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN SYSTEM; MAINTAINER, SPACE PREFORMED, ORTHODONTIC

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ALIGN TECHNOLOGY, INC. INVISALIGN SYSTEM; MAINTAINER, SPACE PREFORMED, ORTHODONTIC Back to Search Results
Model Number VIVERA RETAINER
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Chest Pain (1776); Headache (1880); Pain (1994); Discomfort (2330)
Event Date 12/01/2018
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 chest pain while an align product was being used.
 
Event Description
The patient reported discomfort, headaches, tmd (tmj pain), ringing of the ears and chest pain.The patient reported visiting the er and a physician, due to the chest pain.The patient reported being prescribed medications (unspecified) to alleviate the reported symptoms.The treatment has not been discontinued as the patient is still wearing the vivera retainers.
 
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Brand Name
INVISALIGN SYSTEM
Type of Device
MAINTAINER, SPACE PREFORMED, ORTHODONTIC
Manufacturer (Section D)
ALIGN TECHNOLOGY, INC.
2820 orchard parkway
san jose CA 95134
Manufacturer Contact
ryan hoffmeister
2820 orchard parkway
san jose, CA 95134
MDR Report Key8220029
MDR Text Key132203195
Report Number2953749-2018-02412
Device Sequence Number1
Product Code DYT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberVIVERA RETAINER
Device Catalogue Number8577
Device Lot Number26620765
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2018
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age33 YR
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