MAUDE Adverse Event Report: CLEARCORRECT CLEARCORRECT SYSTEM; CLEAR PLASTIC ORTHODONTIC ALIGNER

Lot Number	1888921
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Subclinical Infection (2247)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clearcorrect findings: a review of case #(b)(4) shows no errors in the treatment plan that would contribute the reported issue.The customer has submitted a revision due to incomplete movements at tooth 8 & 9.The patient is slightly behind treatment.Clinical evaluation: the complaint of a pink incisor is supported by the provided photograph.The color change is suggestive of an erythematous phenomenon potentially as a an aspect of internal resorption.The periapical radiograph is suggestive of very minor root apex resorption if any at all.No information is provided regarding additional clinical information, signs and symptoms, or resolution.Although idiopathic internal root resorption associated with orthodontic tooth movement is extremely rare, no definitive cause and effect have been established.This phenomenon also occurs in the absence of tooth movement.Nevertheless, if not already done, it is suggested that the patient be referred to an endodontist or other appropriate dentist for further evaluation and management.
Event or Problem Description
The incisor of the patient changed color and became pink.

• Brand Name: CLEARCORRECT SYSTEM
• Common Device Name: CLEAR PLASTIC ORTHODONTIC ALIGNER
• Manufacturer (Section D): CLEARCORRECT; 21 cypress blvd; suite 1010; round rock TX 78665
• Manufacturer (Section G): CLEARCORRECT; 21 cypress blvd; suite 1010; round rock TX 78665
• Manufacturer Contact: david jue ; 21 cypress blvd; suite 1010; round rock, TX 78665 ; 8883313323
• MDR Report Key: 22061470
• Report Number: 3007130440-2025-00006
• Device Sequence Number: 20949565
• Product Code: NXC
• UDI-Device Identifier: D865REF03001
• UDI-Public: +D865REF03001/$$52610430948035/16D20241015
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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 Expiration Date: 04/14/2026
• Device Lot Number: 1888921
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• 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: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Unknown