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 11/08/2023

Event Type  Injury  

Manufacturer Narrative

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," and "health of the bone and gums which support the teeth may be impaired or aggravated".The treating doctor shared that the potential root cause of this event could have been super tight retainers.Based on the available information, the patient reported an anticipated tooth extraction and implant (tooth #28) and the vivera retainers product was being used, and therefore, this event is being filed as an mdr.

Event Description

The patient reported symptoms of tight vivera retainers which broke a crown (tooth #28) when removing the retainers, leading to an anticipated extraction (tooth #28) and an implant required (tooth #28).The patient reported requiring going to general dentist to alleviate the reported symptoms.The patient did not report requiring any prescription medications to alleviate the reported symptoms.The patient reported discontinuing the use of the retainers on (b)(6) 2023, but the condition has not improved.

• 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: 18215827
• MDR Text Key: 329110435
• Report Number: 2953749-2023-03391
• Device Sequence Number: 1
• Product Code: DYT
• UDI-Device Identifier: 00816063020028
• UDI-Public: (01)00816063020028(10)0163054743(13)230928(91)1790665501R
• 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: Dentist
• Type of Report: Initial
• Report Date: 11/28/2023

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: 163054743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• 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: 36 YR
• Patient Sex: Male