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 01/01/2024

Event Type  Injury  

Event Description

The patient directly reported the following: the patient reported symptoms of retainer tightness and tooth loss (upper right molar).It is unknown if the patient required any medical intervention to alleviate the reported symptoms.It is unknown if the patient took or was prescribed any medication to alleviate the reported symptoms.It is unknown if the patient is still wearing the retainers and the current condition of the patient is unknown.

Manufacturer Narrative

The current instructions for use (ifu) contains the following: "precautions - 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.From 2020 records (photos only, no x-rays available), align's clinical assessment indicates that the patient had extensive amalgam restoration on molars, which were not properly adjusted to teeth surfaces.The 2020 patient photos show no evidence of a pre-existing tooth fracture or root canal treatment on the affected upper right molar.The patient's current retainers were manufactured with a scan submitted from 2021.No conclusive evidence has been provided that supports or opposes the fact that the vivera retainers caused or contributed to the reported symptoms of tooth loss.This event is being filed as an mdr as the patient reported tooth loss (serious injury) and the vivera retainers product was being used.

• 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 (Section G): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: harper shore ; 3030 slater road; morrisville, NC 27560 ; 4084701343
• MDR Report Key: 18692195
• MDR Text Key: 335196012
• Report Number: 2953749-2024-00149
• Device Sequence Number: 1
• Product Code: DYT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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: 168575709
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 62 YR
• Patient Sex: Female