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

Model Number	424-926RN
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	01/09/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ORTHODONTIC APPLIANCE
• Manufacturer (Section D): ORTHO ORGANIZERS, INC.; 1822 aston ave; carlsbad, ca
• MDR Report Key: 10693786
• Report Number: 2081322-2020-00001
• Device Sequence Number: 11503653
• Product Code: EJF
• UDI-Device Identifier: 00190707023416
• UDI-Public: 00190707023416
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 424-926RN
• Device Catalogue Number: 424-926RN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR