MAUDE Adverse Event Report: ORTHO ORGANIZERS, INC CARRIERE MOTION CLASS II; BRACKET, METAL, ORTHODONTIC

Model Number 424-925CN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tooth Fracture (2428)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

The orthodontist removed as much composite as possible from around ul3 and ul6 and used a bracket removing plier to squeeze between the pad and tooth.A 1mm divot of enamel was missing from the buccal surface of tooth ul6.The orthodontist bonded a small amount of flowable composite to the fractured enamel.He switched bonding agents approximately 9 months ago due to excessive bond strengths he was experiencing, which may have led to the fractured enamel.Device not returned.

Event Description

When removing the carriere motion appliance from tooth number 14, a small fracture of enamel broke off with the appliance located on the buccal side.

• Brand Name: CARRIERE MOTION CLASS II
• Type of Device: BRACKET, METAL, ORTHODONTIC
• Manufacturer (Section D): ORTHO ORGANIZERS, INC; 1822 aston avenue; carlsbad CA 92008 7306
• Manufacturer (Section G): ORTHO ORGANIZERS, INC.; 1822 aston avenue; carlsbad CA 92008
• Manufacturer Contact: mary pearman ; 1822 aston avenue; carlsbad, CA 92008
• MDR Report Key: 6599793
• MDR Text Key: 76234392
• Report Number: 2081322-2017-00003
• Device Sequence Number: 1
• Product Code: EJF
• UDI-Device Identifier: 00190707023362
• UDI-Public: 00190707023362
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 424-925CN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 13 YR