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	Tooth Fracture (2428)
Date of Event	02/05/2026
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 contribute to the reported event.Thi event is being filed as a mdr since the patient reported symptoms or physiogical conditions related to a facture/chipped tooth.
Event or Problem Description
The provider/patient reported the following: doctor is noticing a "chipping" along the incisal edge that was not present before beginning treatment and wants to know if it is aligner related.

• 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: 24464408
• Report Number: 3015179606-2026-00005
• Device Sequence Number: 15954436
• 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): 02/26/2026

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-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: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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: 17 YR
• Patient Sex: Female