MAUDE Adverse Event Report: CANDID CARE CO CANDID ALIGNER SYSTEM; ALIGNER SEQUENTIAL

Model Number FA-0001

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Loss of Range of Motion (2032)

Event Date 03/25/2024

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 tmj.

Event Description

Patient stated the following:shortly after i started using them [step 3], i started having trouble with the left side of my jaw locking up.Currently i am unable to open my mouth fully without the left side locking up and preventing me from opening up further.This issue has been ongoing for almost a day now.

• Brand Name: CANDID ALIGNER SYSTEM
• Type of Device: 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 ; 8312471415
• MDR Report Key: 19122296
• MDR Text Key: 340339020
• Report Number: 3017264-2024-00005
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00850004223567
• UDI-Public: 00850004223567
• 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: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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: 25 YR
• Patient Sex: Male