MAUDE Adverse Event Report: ORMCO CORPORTATION INSIGNIA; ORTHODONTIC PLASTIC BRACKET

Catalog Number 3791506*1*1

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor alleged that a patient had experienced the root of a lower incisor moving too far out and gum recession on that same tooth while receiving orthodontic treatment with the insignia clear product.

Manufacturer Narrative

The doctor manually corrected the bracket to move the tooth back into alignment.It was reported that possible tissue regeneration surgery may be required to address the patient's gum recession; however, this information will not be known until the tooth is repositioned.An update will be provided if any new information becomes available.The product involved in the alleged incident was not returned.Due to the customized manufacturing of this product, no evaluation can be conducted without returned product.

• Brand Name: INSIGNIA
• Type of Device: ORTHODONTIC PLASTIC BRACKET
• Manufacturer (Section D): ORMCO CORPORTATION; 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: 4596614
• MDR Text Key: 5484150
• Report Number: 2016150-2015-00013
• Device Sequence Number: 1
• Product Code: DYW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 3791506*1*1
• Device Lot Number: 37915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention