MAUDE Adverse Event Report: DYNAFLEX NORRIS 20/26 BRACKET; ORTHODONTIC BRACKET

Catalog Number 216-014

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Abrasion (1689)

Event Date 10/19/2022

Event Type  malfunction  

Event Description

Patient's enamel was removed during debonding of the bracket -upper right 4 with offset premolar.

• Brand Name: NORRIS 20/26 BRACKET
• Type of Device: ORTHODONTIC BRACKET
• Manufacturer (Section D): DYNAFLEX; 8050 hawk ridge trail; lake st louis MO 63367
• Manufacturer Contact: maureen miller ; 8050 hawk ridge trail; lake st. louis, MO 63367 ; 3144264020
• MDR Report Key: 15756216
• MDR Text Key: 307770033
• Report Number: 1937100-2022-00002
• 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: Dentist
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 216-014
• Device Lot Number: 0211DFM2M4115A4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Prefer Not To Disclose