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

Model Number	INVISALIGN GO PLUS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The treating doctor reported that the patient required an urgent tooth extraction (tooth 3.6) and had symptoms of pain on the vestibular gum and pain when chewing.No additional information or records are available at this time.
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".Align's clinical review of available records indicate that the affected molar had a crown; however, as no x-rays were shared, the periodontal condition and pre-treatment tooth prognosis cannot be confirmed.No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused or contributed to the reported symptoms.This event is being filed as an mdr per 21 cfr 803 as a serious injury occurred, and the invisalign system aligners were being used.The date of event (b3) is based on the timelines reported to align by the complainant and compared to the patient information.There is no conclusive evidence to confirm the date of the reported symptoms.

• 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: 19968061
• Report Number: 2953749-2024-02111
• Device Sequence Number: 8810543
• Product Code: NXC
• UDI-Device Identifier: 00816063020431
• UDI-Public: (01)00816063020431(10)0187103219(13)240610(91)24049719XXN
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/12/2024

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 GO PLUS
• Device Catalogue Number: 9012
• Device Lot Number: 187103219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2024
• 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: 46 YR
• Patient Sex: Female