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

Model Number	INVISALIGN LITE
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported symptoms of pain, tenderness, mobility, gingival recession, swelling, tooth loss (patient extracted tooth 2.2 themself).It is unknown if the patient has dental trauma, but the treating doctor shared that they suspect trauma in the area.The patient did not report requiring any medical intervention to alleviate the reported symptoms.The patient did not report taking or being prescribed any medication to alleviate the reported symptom.
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "precautions - existing dental restorations (e.G: crowns, bridges) may become dislodged and require re-cementation or, in some instances, replacement," "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," "the health of the bone and gums which support the teeth may be impaired and aggravated," and "dental tenderness may be experienced following initial aligner placement and after switching to each new aligner in the series." the treating doctor shared that the potential root cause of this event could have been trauma against the tooth (patient is a football player).Doctor had a discussion with the periodontist.No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused the reported symptom.This event is being filed as an mdr as the patient reported tooth loss (serious injury) and the invisalign product was being used.

• Brand Name: INVISALIGN SYSTEM
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: aaheli poddar ; 2820 orchard parkway; san jose, CA 95134 ; 4084701340
• MDR Report Key: 15462868
• Report Number: 2953749-2022-02832
• Device Sequence Number: 6873907
• Product Code: NXC
• UDI-Device Identifier: 00816063020202
• UDI-Public: (01)00816063020202(10)0113706642(13)210922(91)1355959205N
• Combination Product (Y/N): N
• Initial Reporter Country: IC
• PMA/510(K) Number: K181739
• 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): 09/16/2022

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 LITE
• Device Catalogue Number: 8852
• Device Lot Number: 113706642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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: Disability
• Patient Age: 14 YR
• Patient Sex: Male