MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN SYSTEM; ALIGNER, SEQUENTIAL

Model Number	INVISALIGN SYSTEM - LITE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The treating doctor reported that the patient had symptom of a tooth extraction (tooth #6).No additional information or records are available at this time.
Additional 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 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".No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners 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 invisalign system aligners were being used.The date of event (b3) is 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 symptoms.

• Brand Name: INVISALIGN SYSTEM
• Common Device Name: ALIGNER, SEQUENTIAL
• 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: 19534444
• Report Number: 2953749-2024-01616
• Device Sequence Number: 6030929
• Product Code: NXC
• UDI-Device Identifier: 00816063020202
• UDI-Public: (01)00816063020202(10)0182458801(13)240422(91)23952820XXN
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K220287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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 SYSTEM - LITE
• Device Catalogue Number: 9002
• Device Lot Number: 182458801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2024
• 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: 66 YR
• Patient Sex: Female