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

Lot Number	1706371
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Difficulty Chewing (4522)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
"the complaint is one of jaw joint popping during the course of aligner treatment.No additional information regarding pain, limitation of movement, frequency or resolution is provided.Joint noises are incidental and generally of no consequence.Other clinical criteria are utilized to better determine a course of action.Without further details this situation remains isolated and inconclusive.Updated january 28, 2025: temporomandibular joint dysfunction (tmd) is a complex multifactorial disorder.My recommendation is that the patient be evaluated by a dentist who is familiar with the examination, diagnosis and management of patients with tmd to be evaluated comprehensively.Following patient examination, the need for radiographic imaging and other diagnostic tests can be determined.The additional report of intermittent pain does not contribute much to understanding the patient's situation.".
Additional Manufacturer Narrative
Clear correct findings: in reviewing the ticket, the customer states this is happening in the upper jaw.There are no concerns with the upper digital scan received on march 23, 2024.Case timeline: case and digital scans submitted on march 23, 2024 treatment setup sent to customer on (b)(6) 2024 customer approved the treatment setup on (b)(6) 2024 devices were delivered on may 29, 2024 with a patient wear schedule of 2 weeks.Patient should have been completed with step 11 around on (b)(6) 2024.Photos of the patient's current dentition have been requested.Once received the investigation will be updated.Update january 28, 2025: i was able to call the provider, and they confirmed that this popping jaw is actually causing some intermittent pain, also they do not have additional photos to provide.The provider did not determine for sure is there was a limitation of movement for now.Clinical evaluation: the complaint is one of jaw joint popping during the course of aligner treatment.No additional information regarding pain, limitation of movement, frequency or resolution is provided.Joint noises are incidental and generally of no consequence.Other clinical criteria are utilized to better determine a course of action.Without further details this situation remains isolated and inconclusive.Updated january 28, 2025: temporomandibular joint dysfunction (tmd) is a complex multifactorial disorder.My recommendation is that the patient be evaluated by a dentist who is familiar with the examination, diagnosis and management of patients with tmd to be evaluated comprehensively.Following patient examination, the need for radiographic imaging and other diagnostic tests can be determined.The additional report of intermittent pain does not contribute much to understanding the patient's situation.

• Brand Name: CLEARCORRECT SYSTEM
• Common Device Name: CLEAR PLASTIC ORTHODONTIC ALIGNER
• Manufacturer (Section D): CLEARCORRECT; 21 cypress blve; 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: 21323007
• Report Number: 3007130440-2025-00001
• Device Sequence Number: 15627483
• Product Code: NXC
• UDI-Device Identifier: D865REF03001
• UDI-Public: +D865REF03001/$$52532827280080/16D20240524
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Dentist
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 01/21/2025

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: 11/24/2025
• Device Lot Number: 1706371
• 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: 01/21/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2024
• 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: Other
• Patient Age: 31 YR
• Patient Sex: Prefer Not To Disclose