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 Codes	Sore Throat (2396); Swelling/ Edema (4577)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "warnings - in rare instances, some patients may be allergic to the plastic aligner material".The treating doctor shared that the potential root cause of this event could have been the invisalign aligners, or the cheek retractor (not an align product) used when the fixators were placed.At this time, with the available information, no conclusive evidence has been provided that supports or opposes the fact that the invisalign aligners caused or contributed to the reported event.This event is being filed as an mdr as the treating doctor reported that the patient required an adrenaline injection (indicative of a life-threatening reaction), and the invisalign system aligners were being used.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Align continues to monitor for trends.
Event or Problem Description
The treating doctor reported that the patient had symptoms of swollen lips and sore throat.The treating doctor reported that the patient required the following medical intervention to alleviate the reported symptoms: patient visited the hospital.The patient was prescribed with the following medication: adrenaline injection and steroid pills.The treating doctor reported that the patient discontinued the use of the aligners on 04-26-2024 and is currently asymptomatic.

• 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: 19288211
• Report Number: 2953749-2024-01265
• Device Sequence Number: 15626492
• Product Code: NXC
• UDI-Device Identifier: 00816063020431
• UDI-Public: (01)00816063020431(10)0181734956(13)240415(91)2332251001N
• Combination Product (Y/N): N
• Initial Reporter Country: IC
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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: 181734956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 33 YR
• Patient Sex: Female