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

Model Number FA-0001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2024

Event Type  Injury  

Event Description

The provider called in and not the patient.The provider reached out because they were concerned with the ipr for the patient's plan.They said usually the ipr are on consecutive teeth but on the pdf it says #11 and then #21 and are not consecutive and they should be consecutive.While on the phone with the provider it appeared that they were looking at a different treatment plan pdf as the one on file was different for this patient.They said they had already performed an ipr on the tooth that was not needed and they were very upset.The provider sent in the photos of the pdf form they received with this patient's aligner kit.

Manufacturer Narrative

Provider was provide the pdf template to identify which tooth would need an ipr done in the international tooth numbering system (fdi).An updated pdf template was provided in the universal tooth number system on (b)(6) 2023 in the provider portal as additional information for the provider.When the ipr was performed, the provider used the initial pdf template which was based on the fdi tooth numbering system.However the provider thought the fdi pdf template was based on the universal tooth numbering system and performed the ipr on the wrong tooth.Patient is currently in refinements to correct this error by the provider.Based on the information provided by the provider, 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 had an ipr performed on the wrong tooth in error by the provider.

• Brand Name: CANDID ALIGNER SYSTEMS
• 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: 19122302
• MDR Text Key: 340339898
• Report Number: 3017264-2024-00006
• 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: 66 YR
• Patient Sex: Female