MAUDE Adverse Event Report: CANDID CARE CO CANDID ALIGNER SYSTEM; ALIGNER SEQUENTIAL, PRODUCT CODE: NXC

Model Number FA-0001

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Tooth Fracture (2428)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

Based on the information provided by the 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.This event is being filed as an mdr since the patient reported symptoms or physiological condition related to the loss of 3 crowns.

Event Description

The patient reported 3 crowns broke off within 60days.Below is the timeline of events: (b)(6) 2023 - 1 week into step 12 tooth #18 broke off at gum line.(b)(6) 2023 - 3 weeks into step 15 tooth #21 broke at gum line.Patient continued to wear aligners; did not contact candid.(b)(6) 2023 - patient finished treatment & received end of treatment communication from candid.(b)(6) 2024 - patient reported the broken crowns.

• Brand Name: CANDID ALIGNER SYSTEM
• Type of Device: ALIGNER SEQUENTIAL, PRODUCT CODE: NXC
• 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 ; 8312471415
• MDR Report Key: 18691821
• MDR Text Key: 335188921
• Report Number: 3017264291-2024-00002
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female