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

Model Number	INVISALIGN RETAINERS
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient directly reported the following: the patient reported symptoms of issues with the upper four front teeth (tooth mobility and teeth started falling out).The patient reported that the patient is in process for implants for the upper four front teeth and implants are planned for next month.It is unknown if the patient was prescribed any medication to alleviate the reported symptoms.It is unknown if the patient is continuing the use of the retainers.
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "general risks to patients - health of the bone and gums which support the teeth may be impaired or aggravated" 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 potential root cause of this event is unknown.No conclusive evidence has been provided that supports or opposes the fact that the invisalign retainers caused or contributed to the reported symptoms of tooth loss (anticipated) and the need for implants (scheduled next month).This event is being filed as an mdr as the patient reported anticipated tooth loss (serious injury) and an invisalign product was being used.

• Brand Name: INVISALIGN 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: 18536050
• Report Number: 2953749-2024-00004
• Device Sequence Number: 6731670
• Product Code: DYT
• UDI-Device Identifier: 00816063020011
• UDI-Public: (01)00816063020011(10)0048430013(13)190320(91)07571698XXR
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2024

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: INVISALIGN RETAINERS
• Device Catalogue Number: 1011
• Device Lot Number: 48430013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/25/2023
• Initial Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2020
• 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: 52 YR
• Patient Sex: Female