MAUDE Adverse Event Report: ORMCO CORPORATION ORTHODONTIC DAMON BRACES; BRACKET, METAL, ORTHODONTIC

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/01/2019

Event Type  Injury  

Event Description

Tmjd (temporomandibular joint disorder) caused by orthodontics.

• Brand Name: ORTHODONTIC DAMON BRACES
• Type of Device: BRACKET, METAL, ORTHODONTIC
• Manufacturer (Section D): ORMCO CORPORATION
• MDR Report Key: 18641854
• MDR Text Key: 334675105
• Report Number: MW5151054
• Device Sequence Number: 1
• Product Code: EJF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White