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 04/01/2024

Event Type  Injury  

Event Description

The treating doctor reported that patient had tooth extraction of ll7.No additional information is available at this time.

Manufacturer Narrative

The current instructions for use (ifu) contains the following: "general risks to patients - 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 the "health of the bone and gums which support the teeth may be impaired or aggravated".After align's clinical review of the initial records, it is apparent that the patient had several periodontal issues and lack of periodontal support of ll7 prior to the use of the vivera retainers.It was noted that ll7 was the only molar present on lower left on initial records and had a poor prognosis prior to using the vivera retainers.No conclusive evidence has been provided that supports or opposes the fact that the vivera retainers caused or contributed to the reported symptom.This event is being filed as an mdr as the treating doctor reported that the patient had symptom of tooth extraction (serious injury) and the vivera retainers were 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: 19176656
• MDR Text Key: 340975686
• Report Number: 2953749-2024-01035
• Device Sequence Number: 1
• Product Code: DYT
• UDI-Device Identifier: 00816063020028
• UDI-Public: (01)00816063020028(10)0175004035(13)240205(91)15450671XXR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K220287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• 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: 7883
• Device Lot Number: 175004035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2024
• 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: 51 YR
• Patient Sex: Female