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

Model Number INVISALIGN SYSTEM - COMPREHENSIVE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 01/01/2024

Event Type  Injury  

Event Description

The patient directly reported the following: patient reported symptoms of decay in the patient's bottom teeth (teeth unspecified, crowns coming off and needing to be replaced (teeth unspecified), mouth pain, cavities on patient's top teeth (unspecified) and required tooth extraction and implants for #18 and #30 (confirmed by the treating doctor).The patient reported requiring visits to a periodontist and an endodontist to alleviate the reported symptoms.The patient reported being prescribed pain medication (unspecified) to alleviate the reported symptoms.It is unknown if the patient is continuing the use of the aligners and the current condition of the patient is unknown.

Manufacturer Narrative

The current instructions for use (ifu) contains the following: "precautions - existing dental restorations (e.G., crowns or bridges) may become dislodged and require re-cementation or, in some instances, replacement" and "tooth decay, periodontal disease, and permanent markings from stains and decalcification may occur if patients do not brush and floss their teeth properly during treatment or if they consume foods or beverages containing sugar or acids while wearing aligners".The treating doctor shared that there could be a relationship with the use of the aligners and the patient's crowns popping off.The treating doctor did not provide an opinion about the patient's tooth decay and if it could have been caused by the aligners.According to treating doctor, the extractions are needed as the patient's molars are periodontally compromised and unrestorable.This event is being filed as an mdr as the treating doctor reported that the patient had symptoms of required tooth extraction (serious injury) for teeth #18 and #30, and the invisalign system aligners were being used.

Manufacturer Narrative

Align received additional information, about the event from the treating doctor on 01/18/2024.According to the treating doctor, the previous provider did not identify, the patient's pathology infection on teeth.The current treating doctor shared, that the pathology is not related to the use of the aligners.With this updated information, align concludes, that the patient's periodontal disease.Although, may not have been caused by the use of the aligners.Might have been aggravated by the use of aligners.However, there is not enough evidence to support or oppose the relationship between the use of the invisalign system aligners and the reported tooth loss of #18 and #30.

• 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: 18655533
• MDR Text Key: 334721880
• Report Number: 2953749-2024-00131
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• PMA/PMN Number: K220287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: INVISALIGN SYSTEM - COMPREHENSIVE
• Device Catalogue Number: 9000
• Device Lot Number: 140363005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2023
• 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: 51 YR
• Patient Sex: Female