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 Unspecified Infection (1930)

Event Date 01/01/2024

Event Type  Injury  

Event Description

The treating doctor reported that the patient had symptoms of inflammation on the palatal tissue of ul1, with a lesion, swelling, infection in the surrounding area, and severe bone loss which necessitated tooth extraction of ul1 and ul2 and additional orthodontic and surgical work to mitigate.Prescribed medications include diluted peridex rinse.The patient has discontinued product use and is currently symptom-free.

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 root lengths of the teeth may be shortened (root resorption) during orthodontic treatment causing a threat to longevity of the teeth" and "orthodontic treatment (including aligner treatment) may impair the health of the bone and gums which support the teeth and may aggravate the gums".The treating doctor shared that the potential root cause of the event could have been an infection that caused significant bone loss on ul1 and ul2.Per align's clinical review of available records, the patient had a periapical rarefaction around ul1 and ul2 apex.It is also evident that the inflammation on ul1 palatal gingiva was present prior the use of invisalign treatment.On more recent records, the periapical rarefaction on ul1 and ul2 increased along with the inflammation on palatal gum of ul1.By the amount of periapical rarefactions evidenced on the x-ray, and the generalized gum smooth texture and palatal gum redness, it is highly possible that this patient started treatment with an active periodontitis.This event is being filed as an mdr as the treating doctor reported that the patient had symptom of tooth extraction of ul1 and ul2 (serious injury) and the invisalign system aligners were being used.The date of event (b3) is an estimated date based on the timelines reported to align by the complainant and compared to the patient information.At the time of this report, there is no conclusive evidence to confirm the date of the reported symptom of tooth extraction of ul1 and ul2.

• 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: 19140036
• MDR Text Key: 340563226
• Report Number: 2953749-2024-00977
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0172585723(13)240110(91)1988593410N
• 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
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 172585723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2024
• 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: 63 YR
• Patient Sex: Female