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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided by the provider/patient, there is no conclusive evidence that supports or opposes the fact that the aligners caused, contributed or would likely cause or conribute to the reported event.This event is being file as an mdr since the patient reported symtoms or physilogical condition related to bone loss.
Event or Problem Description
The provider/patient reported the following: the aligners are shifting my teeth in the wrong direction, causing me to have major bone loss.I'm in jeopardy of losing two up to possibly five teeth.Now they are not shifting my teeth in the direction that i wanted in order for me to be able to eventually get a partial.I am very concerned.Had to go for a week and a half without an aligner in due to the severe pain, shifting bone loss and infection that has set up my x-rays from six months ago looked completely different from what they did this week due to the amount of bone loss and pain i have been experiencing because of the aligners.

• 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: 23662766
• Report Number: 3015179606-2025-00022
• Device Sequence Number: 10231633
• 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): 11/26/2025

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-2002
• Device Lot Number: N/A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2025
• 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: 61 YR
• Patient Sex: Female