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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/01/2022

Event Type  Injury  

Event Description

The patient reported the loss of tooth #13 and tooth #14 is compromised periodontally.It is unknown if the patient required any medical intervention to alleviate the reported symptom.It is unknown if the patient was prescribed any medication to alleviate the reported symptom.It is unknown if the patient is continuing the use of the aligners.

Manufacturer Narrative

The current instructions for use (ifu) pn 206852 contains the following: "precautions - existing dental restorations (e.G., crowns, bridges) may become dislodged and require re-cementation or, in some instances, replacement.No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused the reported symptom.This event is being filed as an mdr as the patient reported implant loss (serious injury) and the invisalign product was being used.

Manufacturer Narrative

Upon review, it was found that the udi field had minor errors.Following is the correction for the udi.D4: udi - (b)(4).

Event Description

This is the first follow up report to 2953749-2022-01956.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: aaheli poddar ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 14978226
• MDR Text Key: 295628340
• Report Number: 2953749-2022-01956
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0113760029(13)220321(91)0958528101N
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181739
• 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
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• 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: 8820
• Device Lot Number: 209317148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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
• Patient Age: 51 YR
• Patient Sex: Female