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

Lot Number	+D865REF03001/$$52625034825017
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
This patient has been getting recession near ll3 due to the aligner digging into her gingivae the patient is currently on step 6.I have had to adjust the patient's aligners here on a few occasions.Could you please re send out the remaining aligners (step 7 to 12) with a shorter flange on ll3 so it terminates above gingival margin? as you can see from the in-situ photo, the ll3 gingivae have recessed on the buccal aspect from the extension on the flange.
Additional Manufacturer Narrative
Clear correct findings: a review of case # (b)(4) confirms that all protocols were followed during its creation, and no deviations were identified that would have led to the reported issue.However, the photos provided with the complaint do show that recession is present.At this time, complaint management is unable to determine the cause of the recession.Clinical evaluation: the complaint is focused on the periodontal tissues around the mandibular left canine.The provided photographs show that the buccal marginal gingiva is erythematous and mildly swollen.The tissue quality appears to be friable lacking the stippling and normal marginal gingival architecture of a rolled border.The provided photographs show the area with the appliance in and without.The former shows that the majority of the affected area is beyond the edge of the aligner.Additionally with the appliance in place, there are no signs of pressure application on this area from the aligner.Although there is insufficient information to determine a cause and effect, the symptoms are more likely related to the periodontal phenotype and status of the patient.

• 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: 22436576
• Report Number: 3007130440-2025-00008
• Device Sequence Number: 3127282
• Product Code: NXC
• UDI-Device Identifier: D865REF03001
• UDI-Public: +D865REF03001/$$52625034825017
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Dentist
• Remedial Action: Notification
• Type of Report: Initial

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: 09/07/2026
• Device Lot Number: +D865REF03001/$$52625034825017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2025
• 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: 21 YR
• Patient Sex: Unknown