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

Lot Number	1646355
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient with case number (b)(4) has had an allergic reaction to the material of the splints supplied.We therefore request a credit note if possible or, alternatively, the provision of splints made from a different material.Please find enclosed the patient's medical certificate.Thank you very much for your assistance.Please do not hesitate to contact me if you have any questions.
Additional Manufacturer Narrative
Clearcorrect findings: no details regarding the specific symptoms of the reported allergic reaction were provided at the time of submission.The customer care representative is currently working with the customer to obtain additional information.The complaint notes that a medical certificate was attached, which was provided in german and translated for the purposes of this investigation.Medical certificate (translated): dear sir or madam, (b)(6) reports experiencing significant oral side effects while using her mouth guard.An intolerance or allergy to one of the ingredients is considered likely.' further updates to the investigation will be documented if additional information becomes available.Clinical evaluation: the complaint is of a potential allergic response to the oral appliance.The attached letter from dr.(b)(6) suggests an intolerance or allergy to a component of the appliance as a likely cause.Unfortunately, there is no other information, history, onset, resolution or photographs to provide essential supportive findings.As such no further insight is possible and the statement from dr.(b)(6) stands.Since a medical professional was sought, this is a reportable event.

• 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: 22992164
• Report Number: 3007130440-2025-00010
• Device Sequence Number: 13114970
• Product Code: NXC
• UDI-Device Identifier: D865REF03001
• UDI-Public: +D865REF03001/$$52529926482662/16D20240502
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 09/05/2025

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 Lot Number: 1646355
• 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: 08/26/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 54 YR
• Patient Sex: Unknown