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

Catalog Number 3571801*1*1*1

Device Problem Insufficient Information (3190)

Patient Problems Tissue Damage (2104); Tooth Fracture (2428)

Event Type  Injury  

Event Description

A doctor alleged that approximately three (3) weeks after placing the 19x25 tma wire into a patient's customized insignia brackets, the root of the ll1 tooth went through the bone.

Manufacturer Narrative

Specific patient information with regard to age and weight was not provided.A doctor alleged that approximately three (3) weeks after placing the 19x25 tma wire into a patient's customized insignia brackets, the root of the ll1 tooth went through the bone.The patient returned to the office where the doctor performed a gum graft and manually corrected the tooth movement by flipping the insignia bracket to express positive torque.Patient has fully recovered and is doing fine at this time.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 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: 4851832
• MDR Text Key: 5812018
• Report Number: 2016150-2015-00018
• Device Sequence Number: 1
• Product Code: DYW
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 3571801*1*1*1
• Device Lot Number: 30039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2015
• 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