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 Tooth Fracture (2428)

Event Date 12/01/2023

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 of this event is unknown.After analysis of the records, align's clinical assessment notes that there was extensive loss of tooth structure and restorative work on tooth 4.7.No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused or contributed to the reported symptoms.This event is being filed as an mdr as the treating doctor reported that the patient had a tooth loss (serious injury) and the invisalign system aligners were being used.

Event Description

The treating doctor reported that the patient had symptoms of broken tooth (4.7) that was unrestorable and resulted in tooth extraction (4.7).It is unknown if the patient required any medical intervention to alleviate the reported symptoms.It is unknown if the patient was prescribed any medication to alleviate the reported symptoms.It is unknown if the patient is continuing the use of the aligners.

Event Description

The treating doctor reported that the patient had symptoms of broken tooth (4.7) that was unrestorable and resulted in tooth extraction (4.7).On (b)(6) 2024, the treating doctor stated that the patient broke tooth 4.7 as an accident that was not related to the invisalign treatment, and reiterated that the tooth 4.7 was unrestorable and needed to be extracted.

Manufacturer Narrative

B5: additional information from treating doctor provided.Based on the information provided, the reported tooth extraction does not appear to be related to the invisalign system aligners.Based on this information, this event is not considered to be a serious adverse event related to the use of align's medical device product.

• 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: 18471104
• MDR Text Key: 332375458
• Report Number: 2953749-2023-03728
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0167450289(13)231114(91)21788019XXN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K220287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• 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: 167450289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2023
• 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: 40 YR
• Patient Sex: Female