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

Model Number INVISALIGN RETAINER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

No test methods have been performed (method 3323) as the product performed in accordance to specifications (conclusion 71) and the device was used in accordance with labeled indications (results 213).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 a mdr since the patient reported reported tooth loss (permanent impairment to a body structure) and the invisalign system aligners were being used at that time.

Event Description

The patient reported symptoms of soreness tooth # 31 (lower right 2nd molar).The patient reported visiting a dentist, who extracted tooth 31, to alleviate the reported symptoms.It is unknown if the patient took or was prescribed any medication due to the reported symptoms.It is unknown if the treatment has been discontinued or if the patient is still wearing the invisalign retainers.The treating doctor did not consider the event was serious or life threatening to the patient.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: MAINTAINER, SPACE PREFORMED, ORTHODONTIC
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2560 orchard parkway; san jose CA 95131
• Manufacturer Contact: ryan hoffmeister ; 2560 orchard parkway; san jose, CA 95131
• MDR Report Key: 6758908
• MDR Text Key: 81559797
• Report Number: 2953749-2017-00691
• Device Sequence Number: 1
• Product Code: DYT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: INVISALIGN RETAINER
• Device Catalogue Number: 1011
• Device Lot Number: 21189577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR