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	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient directly reported the following: the patient reported symptoms of bone loss, tooth extraction (tooth #25 and #26) and implants required (tooth #25 and #26).It is unknown if medical intervention was required to alleviate the reported symptoms.It is unknown if the patient required any prescription medications to alleviate the reported symptoms.The patient reported finishing the invisalign treatment in (b)(6) 2021, and is currently wearing retainers (not an align technology inc.Product).
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "precautions - the root lengths of the teeth may be shortened (root resorption) during orthodontic treatment causing a threat to longevity of the teeth." 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" and "orthodontic treatment (including aligner treatment) may impair the health of the bone and gums which support the teeth and may aggravate the gums".The treating doctor shared that they do not know the potential root cause of the tooth extractions as the extractions were performed by the patient's dentist.The patient reported the following: patient's dentist (not treating doctor) indicated that the reported symptom of bone loss was due to the treatment movement being too fast (as reported by the patient).After align's clinical analysis, there is no evidence of a pre-existing condition on the reported affected teeth (#25 and #26), and buccal movement was programmed on lower anterior to align tooth #24.This event is being filed as an mdr as the patient reported tooth loss (serious injury) and an invisalign product was being used.

• 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: 18566669
• Report Number: 2953749-2024-00112
• Device Sequence Number: 6857783
• Product Code: NXC
• UDI-Device Identifier: 00816063020004
• UDI-Public: (01)00816063020004(10)0059586021(13)191118(91)0745476120N
• Combination Product (Y/N): N
• 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,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2024

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 FULL
• Device Catalogue Number: 8500
• Device Lot Number: 59586021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• 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: 44 YR
• Patient Sex: Male