MAUDE Adverse Event Report: ALIGN TECHNOLOGY INC. INVASALIGN; ALIGNER, SEQUENTIAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Tooth Fracture (2428)

Event Date 03/01/2021

Event Type  Injury  

Event Description

After just twelve days in invisalign four second molars fractured.Three were vertical fractures.One was at the gum line and bled.The pain has been excruciating.I have regular dental check ups and healthy teeth.Fda safety report id# (b)(4).

• Brand Name: INVASALIGN
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY INC.
• MDR Report Key: 11472756
• MDR Text Key: 239735074
• Report Number: MW5099965
• Device Sequence Number: 1
• Product Code: NXC
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 55 YR
• Patient Weight: 59