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

Model Number	INVISALIGN SYSTEM - MODERATE
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Unspecified Infection (1930); Tooth Fracture (2428); Tooth Loss (4831)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "precautions - orthodontic treatment (including aligner treatment) may impair the health of the bone and gums which support the teeth and may aggravate the gums" and "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".The potential root cause was not provided, and the treating doctor is unsure if the reported symptoms are related to the use of the invisalign system aligners.Per align's clinical review of this event, there are no signs of pre-existing clinical conditions that could be related to the reported symptoms.The available records from the primary order show a healthy tooth #30, with no restoration, no cavities, and no bone loss.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 invisalign system aligners were being used.
Event or Problem Description
The treating doctor reported that the patient had symptoms of tooth #30 split in half, infection and tooth extraction (tooth #30).The treating doctor reported that the patient required medical intervention, dentist, to alleviate the reported symptoms of fracture, infection, and the extraction of tooth #30.The treating doctor reported that the patient was prescribed antibiotics to alleviate the reported symptoms.The treating doctor reported that the patient is continuing to use the aligners (requested more aligners through warranty request) and is currently asymptomatic.

• 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: 19043085
• Report Number: 2953749-2024-00805
• Device Sequence Number: 7223467
• Product Code: NXC
• UDI-Device Identifier: 00816063020196
• UDI-Public: (01)00816063020196(10)0169634048(13)231207(91)19804969XXN
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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 - MODERATE
• Device Catalogue Number: 9001
• Device Lot Number: 169634048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2023
• 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: 64 YR
• Patient Sex: Male