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

Model Number	INVISALIGN SYSTEM - MODERATE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tooth Fracture (2428); Tooth Loss (4831)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "contraindication, the invisalign system is contraindicated for use in patients with the following condition: active periodontal disease" and "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".Align's clinical review confirms that the tooth 4.1 had a poor prognosis prior to the use of the invisalign system aligners.No conclusive evidence has been provided that supports or opposes whether the invisalign system aligners contributed to the tooth fracture and required extraction, and therefore this event is being filed as an mdr per 21 cfr 803.
Event or Problem Description
The treating doctor reported that the patient had a fracture in tooth 4.1 and will have to be extracted.The patient was prescribed the following medication: anti-inflammatories and analgesics.The patient reported discontinuing the use of the aligners and the condition has not improved.

• 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 ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 20562025
• Report Number: 2953749-2024-03088
• Device Sequence Number: 19605077
• Product Code: NXC
• UDI-Device Identifier: 00816063020257
• UDI-Public: (01)00816063020257(10)0196807881(13)240917(91)2548848001N
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K241412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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: 196807881
• 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: 10/11/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• 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: 56 YR
• Patient Sex: Female