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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Cognitive Changes (2551)

Event Date 01/31/2014

Event Type  Injury  

Manufacturer Narrative

Ormco corporation was notified by the department of health and human services that a complaint had been registered with regard to the alleged serious injury.Specific patient information was not provided; therefore we are unable to receive further information.The product involved in this incident was not returned therefore no evaluation can be conducted.

Event Description

It was alleged that the orthodontic brackets made the patient mentally unstable and experienced damage to their teeth and gums.

• Type of Device: BRACKET, METAL, ORTHODONTIC
• Manufacturer (Section D): ORMCO CORPORATION; 1332 south lone hill ave.; glendora CA 91740
• Manufacturer Contact: suzette rampair-johnson ; 1332 south lone hill ave.; glendora, CA 91740 ; 9099625730
• MDR Report Key: 7043229
• MDR Text Key: 92466562
• Report Number: 2016150-2017-00006
• Device Sequence Number: 1
• Product Code: EJF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability