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

Catalog Number 3787674*1*1

Device Problems Loose or Intermittent Connection (1371); Failure to Osseointegrate (1863)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor alleged that tooth #11 and tooth #23 felt like they were out of the cortical bone after placement of insignia for a patient.

Manufacturer Narrative

Information with regard to patient age and weight was not provided.Multiple attempts were made to the doctor's office on (b)(6) 2015 to obtain further information; however, the doctor's office has remained unresponsive.The product was not returned; therefore, no evaluations can be conducted.

Manufacturer Narrative

• 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: 4460816
• MDR Text Key: 5321102
• Report Number: 2016150-2015-00003
• Device Sequence Number: 1
• Product Code: DYW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 3787674*1*1
• Device Lot Number: 53675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention