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

Model Number	INVISALIGN SYSTEM - MODERATE
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Ulcer (2274); Swelling/ Edema (4577)
Date of Event	05/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The treating doctor reported that the patient reported the symptoms of swollen tongue, cut on the tongue, infection, and pain.It is noted, that from the hospital certificate, the patient also presented symptoms of white lesions on the tongue, cheeks, and palate.The patient reported requiring a visit to the dental office, where the patient was prescribed anti-inflammatory spray and balm, to alleviate the reported symptoms.It was reported that the treating doctor polished the aligners to remove any sharp edges.The patient reported going back to the dental office and the treating doctor recommended that the patient should go to the hospital.The patient reported hospitalization (patient reported 1 week hospitalization, while hospital certificate reflects 1 day hospitalization on 05/15/23 to alleviate the reported symptoms.The patient reported being diagnosed at hospital with glossitis.While in the hospital, the patient reported being prescribed anti-inflammatory, analgesics, and intravenous antibiotics to alleviate the reported symptoms.The treating doctor reported that the patient discontinued the use of the aligners around (b)(6) 2023.Hospitalization was reported to have occurred on 05/15/23 and the patient is now doing fine, and wanting to resume invisalign treatment.
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "precautions: gums, cheeks, or lips may be scratched or irritated by the product." the mother of the patient shared that the potential root cause of this event could have been a manufacturing defect: sharp edges on the aligners.During investigation of this event, manufacturing images were obtained for aligner stage #7 (the aligners that were being used at time of this event) and the image (attached to this report) of the aligner depicts a "burr" on the upper aligner.The burr was not able to be replicated when aligner stage #7 was reproduced for investigational purposes at the manufacturing site.Based on the available information, the patient reported requiring hospitalization and intravenous antibiotics, and the invisalign system product was being used.Therefore, this mdr is being filed, as the event involved hospitalization and could have been potentially life-threatening to the patient.

• 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: 18131937
• Report Number: 2953749-2023-02846
• Device Sequence Number: 7715681
• Product Code: NXC
• UDI-Device Identifier: 00816063020196
• UDI-Public: (01)00816063020196(10)0129317352(13)220919(91)1811611107N
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/14/2023

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: 129317352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• 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: Life Threatening; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Female