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

Model Number VIVERA RETAINER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 03/09/2018

Event Type  Injury  

Manufacturer Narrative

No test methods have been performed as the product performed in accordance to specifications and the device was used in accordance with labeled indications.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 a permanent impairment to a body structure and the vivera retainer was being used at that time.

Event Description

The patient reported having teeth # 3 (upper right 1st molar) and 4 (upper right 2nd premolar).The patient reported visiting a dentist and an endodontist, and a root canal was performed on teeth # 3 and 4 (unspecified by which doctor), to alleviate the reported symptom.However, the root canals both failed and became infected.On 3/9/18 the endodontist extracted teeth # 3 and 4 due to the infection.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.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: ryan hoffmeister ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 7364059
• MDR Text Key: 103267180
• Report Number: 2953749-2018-00371
• Device Sequence Number: 1
• Product Code: DYT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VIVERA RETAINER
• Device Catalogue Number: 8579
• Device Lot Number: 10708939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2015
• Is the Device Single Use?: No
• 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: 63 YR