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

Model Number	INVISALIGN ASSIST
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	10/01/2023
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," "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 potential root cause is unknown.There is no conclusive evidence suggesting that the event was caused by the invisalign system aligners.This event is being filed as an mdr as the patient reported tooth loss (serious injury) and the invisalign product was being used.
Event or Problem Description
The patient reported tooth loss (unknown tooth), pain and swollen gums around front tooth.The patient reported visiting a general dentist to alleviate the reported symptoms.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 invisalign system aligners.

• 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: aaheli poddar ; 100 queens quay e; toronto, ontario M5E1Z-2 ; CA M5E1Z2
• MDR Report Key: 17984175
• Report Number: 2953749-2023-03073
• Device Sequence Number: 18212229
• Product Code: NXC
• UDI-Device Identifier: 00816063020080
• UDI-Public: (01)00816063020080(10)0161358428(13)230911(91)16036664XXN
• 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: Consumer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/20/2023

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 ASSIST
• Device Catalogue Number: 8534
• Device Lot Number: 161358428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 35 YR
• Patient Sex: Female