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

Model Number	INVISALIGN LITE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The treating doctor reported that the patient had tooth extractions of tooth 2.3 and 2.1, requiring implants, and cervical resorption on tooth 1.3 and 2.2.The patient's last order was in 2016.
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "precautions - the health of the bone and gums which support the teeth may be impaired or aggravated" and "the length of the roots of the teeth may be shortened during orthodontic treatment, which may become a threat to the longevity of the teeth" 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 confirmed that there were other risk factors that may have contributed to root resorption and the patient's treatment was 8-9 years ago.No conclusive evidence has been provided that supports or opposes whether the invisalign system aligners contributed to root resorption and the required tooth extractions (permanent impairment), therefore, this event it is being filed as an mdr.There is no conclusive evidence to confirm the date of the required tooth extractions, and the date (b3) is based on the timelines reported to align and compared to the patient information.
Additional Manufacturer Narrative
Adding product-specific information after further device record analysis.

• 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: janier duarte santana ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 20843398
• Report Number: 2953749-2024-03366
• Device Sequence Number: 14392176
• Product Code: NXC
• UDI-Device Identifier: 00816063020066
• UDI-Public: (01)00816063020066(10)0019762978(13)160402(91)03952543XXN
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K241412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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 LITE
• Device Catalogue Number: 8523
• Device Lot Number: 19762978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2016
• 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: 55 YR
• Patient Sex: Male