MAUDE Adverse Event Report: ORTHO ORGANIZERS, INC. CARRIERE SLX 3D; ORTHODONTIC METAL BRACKET

Model Number	777-UR1-10
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Type of Reportable Event	Malfunction
Event or Problem Description
After a round of routine post-market biocompatibility studies, ortho organizers became aware that a sample of slx 3d orthodontic brackets had failed cytotoxicity testing.
Additional Manufacturer Narrative
After a round of routine post-market biocompatibility studies, ortho organizers became aware that a sample of slx 3d orthodontic brackets had failed cytotoxicity testing.The organization is currently conducting an investigation under an internal capa.

• Brand Name: CARRIERE SLX 3D
• Common Device Name: ORTHODONTIC METAL BRACKET
• 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: 13550087
• Report Number: 2081322-2022-00001
• Device Sequence Number: 5023826
• Product Code: EJF
• UDI-Device Identifier: 00190707048402
• UDI-Public: 00190707048402
• 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: 777-UR1-10
• Device Catalogue Number: 777-UR1-10
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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