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

Model Number	Aligner (Multi-layer)
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clearcorrect findings: a review of case #( b)(4) shows the phase 1 aligners arrived in the customer's office on (b)(4) 2022, with a patient wear schedule of 1 week.The patient should have been at step 9 around (b)(6), 2022.Incomplete movements may be a contributing factor, however, the photos received are inconclusive in determining this.The patient states they were using water and a toothbrush to clean to the devices at the beginning of treatment, but recently starting using a specific product given to them by their dentist.The product name was not provided.Clinical evaluation: the primary complaint relates to sores on the tongue.No clinical examination information or photographs were provided.There is no mention of aligner fitment, sharp edges or other discomfort.A variety of conditions such as apthous ulcers, herpes simplex outbreak, hormonal conditions, nutritional deficiencies and others are known to be related to sores on the tongue.A secondary complaint was that the inside of the mouth was red and sensitive.As with the primary complaint, there are also a number of conditions that are associated with this.With the limited information provided, no clear etiology or cause and effect can be established.It is suggested that a comprehensive clinical examination including photographs be performed.
Event or Problem Description
Patient has been experiencing very sore and swollen tongue.Tongue is sensitive to salt and heat, and he is experiencing loss of taste.Patient says the whole mouth feels slightly numb and is experiencing a tingling sensation.Says that after a week of not wearing aligners the symptoms seemed to disappear, however, that after wearing them again they returned.It was recommended to the provider to stop treatment and have the patient do an allergy test and for a quick test to do a skin test to see if this would result in a rash or other reaction.Patient responses: what is the current step and arch being discussed? step 9 the dentist advised me to stop wearing the clearcorrect and also to test with a piece of the plastic cut off the older braces and tape it on my skin.To see if any rash appears.Presence of a rash? the inside of my mouth was very red and sensitive to heat and salt.Presence of sores? yes, there were some sores on my tongue.Presence of swelling? yes, my tongue was swollen: presence of fever? no.Difficulty breathing? no.Known allergy to plastic? no.Any allergies to disinfectants? no.Was the product rinsed at seating? yes.What was used to clean the product? water and a toothbrush in the beginning.Last week i also used the specific product given by the dentist to clean it every 4 days.Does the product appear to be clean? yes.Only sometimes during the day i noticed some "scale/tarnish", but this was cleaned in the evening.Has the patient seen an allergist no.I'm starting to think it's not really an allergy for the plastic.But the burning mouth syndrome induced by the clearcorrect.

• Brand Name: CLEARCORRECT SYSTEM
• Common Device Name: 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 ; 8883313323
• MDR Report Key: 16656579
• Report Number: 3007130440-2023-00001
• Device Sequence Number: 15272395
• Product Code: NXC
• UDI-Device Identifier: D865REF00031
• UDI-Public: +D865REF00031/$$52336311159219/16D20220630
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K113618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2023
• Device Model Number: Aligner (Multi-layer)
• Device Catalogue Number: REF-03
• Device Lot Number: 75002521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White