MAUDE Adverse Event Report: CANDID CARE CO. CANDID ALIGNER SYSTEM; 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	03/05/2026
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 a 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:" we put together a candid txp together in (b)(6) 2025.Throughout treatment the patient has had concerns about her bite not coming together at all, at one point it started causing some symptoms of tmd.I saw her on (b)(6) 2025 and noted she was having premolar interferences on both sides in her occlusion that was preventing any other teeth from occluding.At that time i encouraged her to be patient that these interferences would move out of the way and her bite would come together.She is now on aligner 21 of 25 and still reports she cannot close down/can't bite.The patient is coming on next week monday for me to take a look.I was just reviewing her treatment plan at stage zero and comparing it to our photos and am starting to get concerned that the bite was off in the digital candid treatment plan starting point.If you look at the candid plan and compare it to the photos it appears the digital setup at stage zero has a lot more overjet on teeth #12 and 13 (where her occlusal interference is) when compared to the photos i submitted.Hopefully i'm wrong about this but wanted you to review and hear your thoughts.Should we consider stopping and re-scanning or having her finish the treatment then consider refinement or bite adjustment.".

• Brand Name: CANDID ALIGNER SYSTEM
• 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: 24716237
• Report Number: 3015179606-2026-00011
• Device Sequence Number: 17562093
• 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): 03/27/2026

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-0002
• 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: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2025
• 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: 62 YR
• Patient Sex: Female