MAUDE Adverse Event Report: CANDID CARE CO. CANDID ALIGNER SYSTEMS; ALIGNER SEQUENTIAL

Model Number	FA-0001
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Joint locking (2672)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided by the provider/patient, there is no evidence that supports or opposes the fact that the aligners caused, contributed or would likely cause or contribute to the reported event.This event is being file as an mdr since the provider/patient reported symptoms or physiological condition related to temporomandibular disorder (tmd).
Event or Problem Description
The provider/patient reported the following: the patient, (b)(6), (b)(6), reached out to advise that she had stopped wearing her aligners because she was experiencing jaw spasms and ear spluttering.When she got to the 11th set, she wore it for one night, and when she woke up, her left ear was spluttering, so she went to set 10 and the fluttering continued for like a month, she went back to nine while the emt checked on her, went back to the dentist to check her jaw because it was bothering her ears.The jaw spasms started when wearing number 9.The teeth were back to the way they were, and she's trying to get a refund because of the terrible experience.

• Brand Name: CANDID ALIGNER SYSTEMS
• Common Device Name: ALIGNER SEQUENTIAL
• Manufacturer (Section D): CANDID CARE CO.; 1200 chambers road; suite 307; columbus OH 43212
• Manufacturer (Section G): CANDID CARE CO.; 1200 chambers road; suite 307; columbus OH 43212
• Manufacturer Contact: jim churchill ; 1200 chambers road; suite 307; columbus, OH 43212 ; 8442956915
• MDR Report Key: 23733490
• Report Number: 3015179606-2025-00021
• Device Sequence Number: 9834665
• Product Code: NXC
• UDI-Device Identifier: 00850004223567
• UDI-Public: 00850004223567
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K190948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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
• Device Model Number: FA-0001
• Device Catalogue Number: FGS-0008
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2025
• Is the Device Labeled for Single Use? (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: 55 YR
• Patient Sex: Female