MAUDE Adverse Event Report: ORTHO ORGANIZERS, INC. CARRIERE MOTION 3D COLORS CLASS II; ORTHODONTIC APPLIANCE

Model Number 424-916CN

Device Problem Insufficient Information (3190)

Patient Problem Tooth Fracture (2428)

Event Type  Injury  

Event Description

Upon debonding of a carriere motion 3d color class ii 16 mm (silver) device by the doctor's assistant, the (b)(6) female patient experienced shearing of the facial surfaces of both upper canine teeth (teeth # 6 and 11).According to the doctor's complaint, the 3d motion device had been attached to the etched canines with transbond adhesive bond material.

Manufacturer Narrative

On december 3rd, 2021, ortho organizers, inc.Became aware of an adverse event involving the carriere motion 3d color class ii appliance.The complaint received from the clinician states that upon debonding of a carriere motion 3d color class ii 16 mm (silver) device by the doctor's assistant, the (b)(6) female patient experienced shearing of the facial surfaces of both upper canine teeth (teeth # 6 and 11).The device was not saved by the orthodontics office and thus could not be returned to ortho organizers for investigation.The patient questionnaire was not returned to us, even after several attempts of contacting the doctor's office.

• Brand Name: CARRIERE MOTION 3D COLORS CLASS II
• Type of Device: ORTHODONTIC APPLIANCE
• Manufacturer (Section D): ORTHO ORGANIZERS, INC.; 1822 aston ave; carlsbad CA 92008
• Manufacturer (Section G): ORTHO ORGANIZERS, INC.; 1822 aston ave; carlsbad CA 92008
• Manufacturer Contact: wendy garman ; 1822 aston ave; carlsbad, CA 92008 ; 7604488600
• MDR Report Key: 13113070
• MDR Text Key: 285607179
• Report Number: 2081322-2021-00002
• Device Sequence Number: 1
• Product Code: EJF
• UDI-Device Identifier: 00190707023096
• UDI-Public: 00190707023096
• 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: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 424-916CN
• Device Catalogue Number: 424-916CN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• 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): Disability
• Patient Age: 37 YR
• Patient Sex: Female