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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 04/28/2023

Event Type  Injury  

Event Description

The patient reported symptoms of severe pain and tooth loss (unknown tooth #, however it was noted that this tooth had crown).This event was directly reported to the fda by the patient as a medwatch report (mw5117721) and no identifiable information about the patient nor the treating doctor's office was disclosed.It is unknown if the patient required medical intervention or if the patient was prescribed medication to alleviate the reported symptoms.It is unknown if or when the patient discontinued the use of the aligners or retainers.

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." no conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners or retainers caused or contributed to the reported symptom of tooth loss.This event is being filed as an mdr as the patient reported tooth loss (serious injury) and the invisalign system aligners or retainers were reportedly being used.This mdr is being filed by the company after receiving medwatch report mw5117721 and evaluating the available information.

• 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: 17182846
• MDR Text Key: 317732001
• Report Number: 2953749-2023-01961
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Disability