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

Model Number	INVISALIGN SYSTEM - MODERATE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Tooth Loss (4831)
Date of Event	07/01/2024
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".Align's clinical review of available records indicate that tooth ur1 had a poor prognosis prior the use of treatment (pre-existing root canal treatment and metal-porcelain crown with traumatic occlusion).No conclusive evidence has been provided that supports or opposes that the invisalign system aligners caused or contributed to the reported symptoms.This event is being filed as an mdr as the treating doctor reported that the patient had tooth extraction (serious injury), and the invisalign system aligners were being used.The date of event (b3) is based on the timelines reported to align and compared to the patient information.There is no conclusive evidence to confirm the date of the reported symptoms.
Event or Problem Description
The treating doctor reported that the patient had symptoms of severe abscess on ur1 and tooth extraction (ur1).No additional information is available at this time.

• 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: 20081234
• Report Number: 2953749-2024-02528
• Device Sequence Number: 7810963
• Product Code: NXC
• UDI-Device Identifier: 00816063020196
• UDI-Public: (01)00816063020196(10)0186824569(13)240607(91)19560727XXN
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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: 186824569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• 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: 35 YR
• Patient Sex: Female