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

Model Number INVISALIGN SYSTEM - LITE

Device Problem Appropriate Term/Code Not Available (3191)

Event Date 09/01/2023

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 or aggravated"; and "the length of the roots of the teeth may be shortened during orthodontic treatment, which may become a threat to the longevity of the teeth." 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 symptoms.This event is being filed as an mdr as the patient reported tooth loss (serious injury) and the invisalign system aligners were being used.

Event Description

The patient reported symptoms of tooth extraction and crown done (tooth unspecified; however, after reviewing records, the afflicted tooth may be tooth #14).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.It is unknown if the patient is still wearing the aligners.

• 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: 17896021
• MDR Text Key: 325244079
• Report Number: 2953749-2023-02911
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00816063020202
• UDI-Public: (01)00816063020202(10)0152814306(13)230609(91)2058147201N
• 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: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: INVISALIGN SYSTEM - LITE
• Device Catalogue Number: 9002
• Device Lot Number: 152814306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• 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: 58 YR
• Patient Sex: Female