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

Catalog Number 491-6590

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

An orthodontic office reported that it was alleged by a dentist that a patient had dislodged a damon q bracket and there were signs of enamel damage upon removal.

Manufacturer Narrative

It was reported by the orthodontic office that the dentist had removed the loose bracket and filled in the damaged area of the enamel.The date of the repair and product used was unknown by the reporting orthodontic office.To date, the patient is doing fine.The product involved in the alleged incident was not returned and no lot number was provided; therefore, no evaluation can be conducted.

• Brand Name: DAMON Q
• Type of Device: BRACKET, METAL, ORTHODONTIC
• Manufacturer (Section D): ORMCO CORPORATION; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer (Section G): ORMCO CORPORATION; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer Contact: kerri casino ; 1717 w collins ave; orange, CA 92867 ; 7145167634
• MDR Report Key: 3640809
• MDR Text Key: 22264598
• Report Number: 2016150-2014-00008
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 491-6590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention
• Patient Age: 13 YR