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)

Event Date 11/15/2023

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 conditions related to tooth breakage which the customer stated resulted in extraction of the tooth.

Event Description

This is a summary of the reported event: initial report 09/21/2023: patient reached out to report his second aligner step, which caused him throbbing pain.Especially the back of his molars, feels like pushing them too much.Everything is swollen."throbbing, i guess.It feels like pulsations (or, at least, the lower molar on the right side feels like it is pulsating).It is the molar at the very back, which has no recent history of pain and, in fact, was filled some time ago (no visible cavities).The pain extends to the lower jaw on the right side.Earlier today, it was unbearable.Right now, it is becoming way more manageable, but the discomfort and pain are still present.I can't chew or bite on that side because then the pain comes back, with a very sharp triggering pain when i bite" additional information was requested from the patient 3 times with no response.The initial complaint was closed.On 11/15/2023, complaint was reopened because the patient reached to out to inform candid, they had an extraction of a molar approximately 1 month ago.This extraction was done in another country which is the reason for the delay in the patient reporting this information to candid.

• 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
• MDR Report Key: 18340718
• MDR Text Key: 330667515
• Report Number: 3017264291-2023-00003
• 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: 12/15/2023

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 Operator: Lay User/Patient
• Device Model Number: FA-0001
• Device Catalogue Number: FGS-0008
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2023
• Is the Device Single Use?: 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: 34 YR
• Patient Sex: Male