MAUDE Adverse Event Report: CLEARCORRECT CLEARCORRECT SYSTEM; CLEAR PLASTIC ORTHODONTIC ALIGNER

Model Number Retainer

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Subclinical Infection (2247)

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

Clearcorrect findings: reviewed the ledger and identified that treatment was scheduled to be completed in (b)(6) 2020, however, retainers were not order until february 2021.Retainer requested was based off the final step of treatment.If movements have not completed or relapse has occurred due to the timeframe between treatment completion and retainer order, the retainer could fit inappropriately and cause tissue irritation.The retainer will need to be returned for further investigation.The fact that the patient did not experience any similar reactions of gum irritation or infections during the aligner treatment process and only experience an infection following the use of the retainer implies that the retainer devices contributed to the event experienced by the customer.Clinical evaluation: the information provided is rather vague and no photographs were provided of the retainer nor the soft tissue issues.These were reported to be "bleeding, swelling, and pain in the left side of his face" and "all over".These symptoms are atypical of retainer-related complaints.The issues are further compound by the patient not having had a dental cleaning since 2000 and advised to do so by a clinician suggesting there may be ongoing issues that need attention.A report from the urgent care was not provided and it is not known if the problems were resolved.There is insufficient information provided to establish a clear relationship between the retainer and the reported problems.Since the retainer is removable, it can be removed to allow for healing.During this time the patient may wear the last phase of the aligners if they are available.Accordingly, the risk to the patient is low.

Event Description

Candid complaint management reported: the patient for case (b)(4) reports cuts, irritation to the gums, and infection from the edges of their retainer.The patient reports that they had to visit a doctor due to infection from the damage from the retainer.When asked where the aligners were rough the patient reports "all over." the patient reported pain and swelling in his face first on (b)(6) 2021 to candid; the complaint was not reported to candid quality until 05/03/2021.The patient reported no issues with the treatment aligners.The patient reported symptoms of bleeding, swelling, and pain in the left side of his face.Additionally, we've (candid) found out that the patient has not had a dental cleaning since (b)(6) 2000.The photos and this information were sent to the patient's orthodontist, and the orthodontist advised that the patient was having gingival inflammation and needed to see a dentist for a cleaning and exam.At this time, the orthodontist advised that the patient may benefit from performing a horizontal trim on the retainer.Clinical notes from the patient's visit to urgent care were requested but have not been provided by the patient.

• Brand Name: CLEARCORRECT SYSTEM
• Type of Device: CLEAR PLASTIC ORTHODONTIC ALIGNER
• Manufacturer (Section D): CLEARCORRECT; 21 cypress blvd; round rock TX 78665
• Manufacturer (Section G): CLEARCORRECT; 21 cypress blvd; round rock TX 78665
• Manufacturer Contact: raquel brown ; 21 cypress blvd; round rock, TX 78665 ; 5122992519
• MDR Report Key: 11952222
• MDR Text Key: 260322888
• Report Number: 3007130440-2021-00003
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: D865REF00041
• UDI-Public: +D865REF00041/$$522247303308/16D20210304
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/04/2022
• Device Model Number: Retainer
• Device Catalogue Number: REF-04
• Device Lot Number: 303308
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR