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

Model Number 777-UR1-10

Device Problem Biocompatibility (2886)

Patient Problem Foreign Body Reaction (1868)

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 296380467
• Report Number: 2081322-2022-00001
• Device Sequence Number: 1
• Product Code: EJF
• UDI-Device Identifier: 00190707048402
• UDI-Public: 00190707048402
• 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: Study
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777-UR1-10
• Device Catalogue Number: 777-UR1-10
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other