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 Problems Unspecified Infection (1930); Tooth Fracture (2428)

Event Date 03/15/2024

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 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 bite may change during treatment; this may result in temporary patient discomfort" and "at the end of treatment, the bite may require adjustment by the doctor".The treating doctor shared that the reported event is related to the use of the aligners (unspecified).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.

Event Description

The treating doctor reported that the patient had symptoms of tmj pain, bite issues, tooth fracture on tooth #30, abscess on tooth #30, and tooth extraction of tooth #30.The patient reported requiring visiting an oral surgeon to alleviate the reported symptoms (tooth extraction performed on (b)(6) 2024).The patient did not report being prescribed any medications to alleviate the reported symptoms.The patient reported discontinuing the use of the aligners (date unknown); however, no progress has been reported to the dental office yet.

• 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: 19105840
• MDR Text Key: 340159149
• Report Number: 2953749-2024-01015
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0176579247(13)240221(91)20627067XXN
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• 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: 176579247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2024
• 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: 58 YR
• Patient Sex: Female