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

Lot Number	2133839
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
We received the new retainer which unfortunately the same as the previous one!! extremely tight and when the patient tried it, she ended up chipping her lower incisor!!!! and her lower teeth are all very sore! it is very tight and we struggled to put it on or take it out!!.
Additional Manufacturer Narrative
Clearcorrect findings: complaint management received a complaint for the retainer shipped on (b)(6) 2025, due to the device being excessively tight.All protocols were followed; however, complaint management submitted an internal retainer request to add additional blocking of the undercuts.Because this is a retainer only case, we do not have original patient photos or x-rays.The photos added to the complaint show the chipped tooth, but they are quite blurry and difficult to see.Clinical evaluation: the complaint is of a chipped mandibular right central incisor and accompanied by photographs of the area.Unfortunately, there are no previous photographs for comparison.In general, teeth that are in satisfactory condition without caries, extensive restorations, a history of trauma and other issues that may compromise their integrity should be able to sustain the forces of removable aligner/retainer wear.Chipped teeth are not a known complication of aligner/retainer wear.Without further documentation, timelines and other details, there is insufficient information to derive any conclusions regarding the etiology of the chipped tooth.Additionally, the degree of damage is very minor and could be alleviated by smoothing the incisal edge or a simple bonded composite restoration without much further consequence.

• Brand Name: CLEARCORRECT SYSTEM
• Common Device Name: CLEAR PLASTIC ORTHODONTIC ALIGNER
• Manufacturer (Section D): CLEARCORRECT; 21 cypress blvd; 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: 22699913
• Report Number: 3007130440-2025-00009
• Device Sequence Number: 12998102
• Product Code: NXC
• UDI-Device Identifier: D865REF04001
• UDI-Public: +D865REF04001/$$52700838562754/16D20250709
• 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
• Report Date (Section B): 07/24/2025

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: 2133839
• 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: 07/24/2025
• Initial Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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: 47 YR
• Patient Sex: Male