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

Catalog Number 3919598*1*1

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A doctor alleged that the insignia jig did not fit; therefore, he removed the brackets from the jig and placed them manually.

Manufacturer Narrative

Specific patient information with regard to age and weight was not provided.A doctor alleged that the insignia jig did not fit; therefore he removed the brackets from the jig and placed them manually.The patient will return for removal of the brackets and a new insignia kit will be created and placed.The device was received in a condition which made analysis impossible; therefore, no further evaluation can be conducted.

• Brand Name: INSIGNIA
• Type of Device: ORTHODONTIC PLASTIC BRACKET
• 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: suzette rampair-johnson ; 1332 s. lone hill ave.; glendora, CA 91740 ; 9099625730
• MDR Report Key: 4865176
• MDR Text Key: 17215803
• Report Number: 2016150-2015-00019
• Device Sequence Number: 1
• Product Code: DYW
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 3919598*1*1
• Device Lot Number: 75940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: No
• 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