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

Model Number 424-926RN

Device Problem Separation Failure (2547)

Patient Problem Tooth Fracture (2428)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

Ortho organizers, inc.Became aware on january 22nd, 2020 of an incident in (b)(6) where a patient's crown was broken during the removal of a bonded carriere motion orthodontic appliance.Ortho organizers received adverse event review questionnaire filled out by the dental clinic in question, the practice of (b)(6) dds, (b)(6) orthodontics.Manufacturer requested lot number and/or for the device to be returned for evaluation, but neither was received.Further investigation is not possible in this case.Tooth fracture during debonding is something that is inherent to orthodontic treatment, and cannot be implicitly attributed to a failure of the device.Incidents of tooth fracture related to debonding of carriere motion 3d appliances will continue to be tracked by the complaint handling procedure within the ortho organizers, inc.Quality management system.

Event Description

Doctor was removing the carriere motion orthodontic appliance from the patient's tooth and the incisal 1/3 of the crown broke off.No pulp exposure but she was extremely sensitive and will need a crown.Doctor removed the appliance using pin and ligature cutters as the patient was biting into a cotton roll.She applied pressure from the gingival and occlusal, and did not torque the tooth.Complaint received by ortho organizers, inc.On (b)(6) 2020.

• Brand Name: CARRIERE MOTION 3D COLORS CLASS II
• Type of Device: ORTHODONTIC APPLIANCE
• Manufacturer (Section D): ORTHO ORGANIZERS, INC.; 1822 aston ave; carlsbad, ca
• Manufacturer Contact: wendy garman ; 1822 aston ave; carlsbad, ca ; 4488600
• MDR Report Key: 10693786
• MDR Text Key: 212080287
• Report Number: 2081322-2020-00001
• Device Sequence Number: 1
• Product Code: EJF
• UDI-Device Identifier: 00190707023416
• UDI-Public: 00190707023416
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 424-926RN
• Device Catalogue Number: 424-926RN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: No
• 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: 29 YR