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 11/01/2023

Event Type  Injury  

Event Description

The patient reported the symptoms of problems with ur7 (unspecified) and tooth extraction of ur7.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.

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.According to align's clinical review, looking at the initial records (x-rays) tooth ur7 was extracted after several treatments, including a large restoration with apparent recurrent decay beneath the dental filling (possibly due to leakage around the dental restoration).The condition of this tooth (ur7) appears compromised and with a reserved prognosis based on this.This event is being filed as an mdr as the patient reported tooth loss (serious injury) and the invisalign system aligners were being used, and there is no conclusive evidence that has been provided that supports or opposes the fact that the invisalign system aligners could have caused or contributed to this reported tooth extraction.

• 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: 18315456
• MDR Text Key: 330326753
• Report Number: 2953749-2023-03467
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 12/12/2023

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: 137525828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• 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: 32 YR
• Patient Sex: Female