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

Model Number INVISALIGN SYSTEM - COMPREHENSIVE

Device Problem Appropriate Term/Code Not Available (3191)

Event Date 04/25/2023

Event Type  Injury  

Manufacturer Narrative

The current instructions for use (ifu) contains the following: "general risks to patients - 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 "health of the bone and gums which support the teeth may be impaired or aggravated".The potential root cause of this event is unknown.Align's clinical assessment of available records from on (b)(6) 2020 indicates that the tooth #2 had a metal porcelain crown with a large metallic space on the occlusal surface that appears similar to a screw access hole that is typically created for implants; however without x-ray records, the type of restoration and tooth periodontal condition cannot be confirmed.From available records from on (b)(6) 2021, the restoration on tooth #2 was modified and a new crown was placed.From warranty request comments from treating doctor on (b)(6) 2023, tooth #2 was reported extracted.No conclusive evidence has been provided that supports or opposes the fact that the invisalign retainers caused or contributed to the reported symptom.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 retainers were being used.

Event Description

The treating doctor reported that the patient had symptom of tooth #2 extracted.It is unknown if the patient required any medical intervention to alleviate the reported symptom.It is unknown if the patient took or was prescribed any medication to alleviate the reported symptom.It is unknown if the patient is continuing to use the retainers and the patient's current condition is unknown.

Event Description

On 03/07/2024, align received the following update from the treating doctor regarding this event: tooth #2 was previously root canal treated and had an existing crown.Tooth #2 was grossly decayed, was non restorable, and needed an extraction which was performed on (b)(6) 2023.

Manufacturer Narrative

The treating doctor updated align on (b)(6) 2024 and clarified the date of the reported tooth extraction.After reviewing the patient's treatment orders and available records, it was found that the patient was using the invisalign system - comprehensive aligners (additional aligners) stage #13 when the reported event occurred.Applicable updates to product information have been made in this report.

• 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: 18842116
• MDR Text Key: 336957600
• Report Number: 2953749-2024-00580
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0131309472(13)221011(91)1014763413N
• 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: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• 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: 131309472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2022
• 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: 46 YR
• Patient Sex: Female