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

Model Number 776-LR4-HK-RP

Device Problem Sharp Edges (4013)

Patient Problem Abrasion (1689)

Event Date 10/20/2022

Event Type  Injury  

Manufacturer Narrative

The carriere slx 3d clear brackets are ceramic, passive, self-ligating orthodontic brackets that directly bond to the teeth to provide a treatment solution for patients with malocclusions of primary, permanent, or mixed dentition.It was reported in the customer complaint form that bracket lr4 in the provided kit had sharp edges causing cheek irritation, cutting the cheek on the lower right of the patient and causing large sores that did not heal.The symptoms began the day after the bracket was placed.The bracket needed to be removed and replaced with a different brand.The 34-year old female patient was prescribed kenalog in orabase, a topical steroid.She was also advised to take otc pain medication such as ibuprofen and tylenol.The doctor indicated in the patient questionnaire that if the device malfunction were to recur, it would not likely cause or contribute to a death or serious injury.Also, no doctor or hospital visit was required, and as indicated in the questionnaire, the patient has fully recovered.Due to the fact that prescription and otc medications were given, ortho organizers decided to report this complaint to the fda.

Event Description

It was reported in the customer complaint form that bracket lr4 in the provided kit had sharp edges causing cheek irritation, cutting the cheek on the lower right of the patient and causing large sores that did not heal.The symptoms began the day after the bracket was placed.The bracket needed to be removed and replaced with a different brand.The 34-year old female patient was prescribed kenalog in orabase, a topical steroid.She was also advised to take otc pain medication such as ibuprofen and tylenol.

• Brand Name: CARRIERE SLX 3D CLEAR
• Type of Device: ORTHODONTIC CERAMIC 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: nicole rajek ; 1822 aston ave.; carlsbad 92008 ; 7604488600
• MDR Report Key: 17847181
• MDR Text Key: 324630574
• Report Number: 2081322-2023-00001
• Device Sequence Number: 1
• Product Code: NJM
• UDI-Device Identifier: 00190707057756
• UDI-Public: 00190707057756
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173440
• 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: 09/29/2023

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
• Device Operator: Health Professional
• Device Model Number: 776-LR4-HK-RP
• Device Catalogue Number: 776-LR4-HK-RP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 34 YR
• Patient Sex: Female