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 Unspecified Infection (1930)

Event Date 01/01/2024

Event Type  Injury  

Event Description

The treating doctor reported that the patient had symptoms of infection and tooth extraction (#9).It is unknown if the patient required any medical intervention to alleviate the reported symptoms.It is unknown if the patient took or was prescribed any medication to alleviate the reported symptoms.The treating doctor reported that the patient is continuing to use the aligners and is currently asymptomatic.

Manufacturer Narrative

The current instructions for use (ifu) contains the following: "precautions - orthodontic treatment (including aligner treatment) may impair the health of the bone and gums which support the teeth and may aggravate the gums" and "a tooth that has been previously traumatized or significantly restored may be aggravated.In rare instances, the 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 treating doctor shared that tooth #9 was planned for extraction towards the end of treatment; however, the patient had to have this tooth removed sooner due to the reported infection.The treating doctor shared that the potential root cause of this event could have been that the infection was exacerbated due to the pressure from the movement of the aligners.This event is being filed as an mdr as the treating doctor reported that the patient had symptom of tooth extraction (serious injury) and the invisalign system aligners were being used.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: 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: 18684675
• MDR Text Key: 335114845
• Report Number: 2953749-2024-00162
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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: 9001
• Device Lot Number: 166096341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 42 YR
• Patient Sex: Female