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

Lot Number	1422839
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clearcorrect findings: the clinician submitted an x-ray of the affected tooth which was taken on (b)(6) 2023.The patient exhibits signs of gum recession and tooth 26 (fdi) appears to be discolored compared to the rest of the dentition based on the case start photos.The treatment plan shows no movement was planned for tooth 26; however, ipr was planned at step 1 between teeth 25-26.No treatment the phase 1 was shipped on (b)(6) 2023 and the manufacturing log shows no defects were detected and all manufacturing protocols were followed.Patient has ceased clear aligner treatment, and clinician stated an implant will be placed and patient will continue with traditional brackets.Clinical evaluation: the accompanying photographs and radiographs show an endodontically treated left maxillary first molar (26) with loss of periodontal attachment and discoloration.Additionally, there is moderate to severe wear of the occlusal table, a very deep bite and skeletal malocclusion.There is osseous ledging/bulbous alveolar ridge, worn incisal edges and cusp tips.These are signs of potential chronic bruxism.The history of endodontic treatment of tooth 26 and the loss of attachment compromise this tooth.The recommendation for endodontically treated teeth is for full crown coverage to avoid tooth fractures.In this case a crown was not on the tooth and the fracture more likely due to these factors than aligner wear.It is noted that this tooth was not actively moved in the aligner design.
Event or Problem Description
Clinician called contacted provider services and stated the patient's tooth was fractured after wearing the devices for one week (from (b)(6) 2023).Patient stated they felt pressure on tooth 26 (fdi) since the first day of treatment.

• 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; round rock TX 78665
• Manufacturer Contact: david jue ; 21 cypress blvd; round rock, TX 78665
• MDR Report Key: 17436813
• Report Number: 3007130440-2023-00003
• Device Sequence Number: 12990173
• Product Code: NXC
• UDI-Device Identifier: D865REF00031
• UDI-Public: +D865REF00031/$$52436318931177/16D20230704
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/01/2023

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: 12/28/2024
• Device Lot Number: 1422839
• 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: 07/28/2023
• Initial Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2023
• 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: 54 YR
• Patient Sex: Female