MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. VIVERA RETAINERS; MAINTAINER, SPACE PREFORMED, ORTHODONTIC

Model Number VIVERA RETAINERS

Device Problem Appropriate Term/Code Not Available (3191)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Due to unsuccessful attempts at contacting the treating doctor, many of the event details were unknown.The current instructions for use (ifu) contains the following: "general risks to patient - a tooth that has been previously traumatized or significantly restored may be aggravated.In rare instances, the useful life of the tooth may be reduced, the tooth may require additional dental treatment such as endodontic and/or additional restorative work, and/or the tooth may be lost." the potential root cause is unknown.No conclusive evidence has been provided that supports or opposes the fact that the vivera retainers caused the reported symptom.This event is being filed as an mdr as the patient reported tooth loss (serious injury) and the vivera retainers were being used.

Event Description

The patient reported tooth #5 cracking down the middle and requiring an implant to address it.It is unknown if the patient required any medical intervention to alleviate the reported symptom.It is unknown if the patient was prescribed any medication to alleviate the reported symptom.It is unknown if the patient is continuing the use of the retainers.

• Brand Name: VIVERA RETAINERS
• Type of Device: MAINTAINER, SPACE PREFORMED, ORTHODONTIC
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: aaheli poddar ; 2820 orchard parkway; san jose, CA 95134 ; 4084701340
• MDR Report Key: 16873630
• MDR Text Key: 314615699
• Report Number: 2953749-2023-01308
• Device Sequence Number: 1
• Product Code: DYT
• UDI-Device Identifier: 00816063020028
• UDI-Public: (01)00816063020028(10)0066398161(13)200416(91)0604847801R
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2023

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: Lay User/Patient
• Device Model Number: VIVERA RETAINERS
• Device Catalogue Number: 8579
• Device Lot Number: 66398161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• 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): Disability
• Patient Age: 59 YR
• Patient Sex: Female