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

Model Number	INVISALIGN FULL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
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 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"; and "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." the treating doctor shared that the potential root cause could have been that the tooth was already affected or possibly due to treatment movement.This event is being filed as an mdr as the patient reported tooth loss (serious injury) and the invisalign system aligners were being used.
Event or Problem Description
The patient reported pustule on the buccal of ll2, near the apex area, root canal was performed, and extraction of tooth ll2.The patient reported requiring visiting an endodontist specialist to alleviate the reported symptoms.The patient did not report taking or being prescribed any medication to alleviate the reported symptoms.The patient is still wearing the aligners 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
• MDR Report Key: 17101120
• Report Number: 2953749-2023-01876
• Device Sequence Number: 19309717
• Product Code: NXC
• UDI-Device Identifier: 00816063020004
• UDI-Public: (01)00816063020004(10)0119041613(13)220519(91)0597131661N
• 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: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/09/2023

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 FULL
• Device Catalogue Number: 8500
• Device Lot Number: 119041613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 63 YR
• Patient Sex: Female