MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN; MAINTAINER, SPACE PREFORMED, ORTHODONTIC

Model Number 9653982

Patient Problems Bone Fracture(s) (1870); Pain (1994); Tooth Fracture (2428)

Event Date 04/01/2023

Event Type  Injury  

Event Description

Wearing invisalign nightly after a year of treatment to maintain my bite, when i changed to a new maintenance pair, i noticed they were tight, and not suppose to feel different, during the night, i fractured badly my lower back tooth and may have a hairline fractured jaw.I've had the split in half fracture taken out and trying to heal, but my jaw is still hurting and waiting now to see a jaw specialist.

• Brand Name: INVISALIGN
• Type of Device: MAINTAINER, SPACE PREFORMED, ORTHODONTIC
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 17966340
• MDR Text Key: 326152018
• Report Number: MW5147105
• Device Sequence Number: 1
• Product Code: DYT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/16/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9653982
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White