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

Model Number	VIVERA RETAINERS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Tooth Fracture (2428); Tooth Loss (4831)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "general risks to patients - existing dental restorations (e.G.- crowns) may become dislodged and require re-cementation or, in some instances, replacement" and "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 treating doctor shared that the patient had not been seen by the office for some time.Align's clinical review of available records indicates that the patient had pre-existing root canal treatment on tooth 1.5 (the only tooth with crown on upper right side) and both lower molars on right side had restorations and poor clinical conditions.No conclusive evidence has been provided that supports or opposes the fact that the vivera retainers caused or contributed to the reported symptoms.This event is being filed as an mdr as the treating doctor reported that the patient had the symptom of tooth extraction (serious injury) and the vivera retainers were being used.B3: the date of event is an estimated date based on the timelines reported to align by the complainant and compared to the patient information.There is no conclusive evidence to confirm the date of the reported symptom of tooth extraction.
Event or Problem Description
The patient directly reported to align the following symptoms, which the treating doctor confirmed: symptoms of a crown falling off of a tooth on the upper right side, tooth became infected and required extraction (unspecified tooth #), and a second lower molar required extraction (unspecified tooth #) with the anterior tooth being chipped.No additional information is available at this time.
Additional Manufacturer Narrative
The patient reported that the invisalign full aligner treatment may have contributed to the reported tooth extractions; however, the patient was using the vivera retainers at the time of the complaint and had been using vivera retainers for the last 6 years.The reported extractions occurred during the use of the vivera retainers.After reviewing the records for the invisalign full and the vivera retainer, there is no evidence of a tooth loss.The same teeth are present, including the restored tooth (crown).There is no conclusive evidence available to support or oppose whether the invisalign full or vivera retainer product contributed or caused the reported tooth loss.

• Brand Name: VIVERA RETAINERS
• Common Device Name: 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: 19383601
• Report Number: 2953749-2024-01378
• Device Sequence Number: 14435906
• Product Code: DYT
• UDI-Device Identifier: 00816063020110
• UDI-Public: (01)00816063020110(10)0032973946(13)180124(91)0563993401R
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: VIVERA RETAINERS
• Device Catalogue Number: 8579
• Device Lot Number: 32973946
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 62 YR
• Patient Sex: Female