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

Model Number	425-425R
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Malfunction
Event or Problem Description
After a round of routine post-market biocompatibility studies, ortho organizers became aware that the motion 3d class ii colors (gold) appliance had failed biocompatibility (irritation) testing.
Additional Manufacturer Narrative
After a round of routine post-market biocompatibility studies, ortho organizers became aware that a sample of carriere motion 3d colors class ii (gold) appliances had failed biocompatibility (irritation) testing.The organization will be conducting an investigation under an internal capa.However, the full test report and laboratory data have not yet been made available by the testing laboratory.The internal investigation will commence upon receipt of the full test report detailing the failure.

• Brand Name: CARRIERE MOTION 3D COLORS CLASS II
• Common Device Name: 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: 13553264
• Report Number: 2081322-2022-00002
• Device Sequence Number: 4313308
• Product Code: EJF
• UDI-Device Identifier: 00190707032715
• UDI-Public: 00190707032715
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 425-425R
• Device Catalogue Number: 425-425R
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown