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

Model Number INVISALIGN SYSTEM - MODERATE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/01/2022

Event Type  Injury  

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 and aggravated." the potential root cause is unknown.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 surgery required to prevent tooth loss (serious injury) and the invisalign product was being used.

Event Description

The patient reported symptoms of gingival impairment/aggravation.The patient reported having emergency gum surgery due to the possibility of losing teeth.It is unknown if the patient was prescribed any medication to alleviate the reported symptom.It is unknown if the patient continuing the use of the invisalign system aligners.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: 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: 15851724
• MDR Text Key: 304180973
• Report Number: 2953749-2022-02440
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• PMA/PMN Number: K181739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: INVISALIGN SYSTEM - MODERATE
• Device Catalogue Number: 8836
• Device Lot Number: 208401429
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female