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

Model Number Aligner (Single-Layer)

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Ulcer (2274)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the case shows no errors in the digital scans received on september 8, 2020.All protocols were followed during the cut and stage process.This patient had a similar situation that was reported on august 26, 2020 under complaint#: (b)(4).The findings from complaint#: (b)(4) show there was an error with manual trimming process and the aligners were over-trimmed.Clinical evaluation for complaint#: (b)(4) states, "it is possible that the over-trimmed aligner margin could expose the patient to an area of roughness and discomfort; best remedy is to replace the affected aligners.There is no cut, or bleeding seen in the photos, but the patient should be advised to discontinue wearing the aligners until replacements arrive.If she does this, there should be negligible medical risk to the patient." due to the report not being a serious injury requiring medical intervention, the event was deemed to be not reportable.The current complaint#: (b)(4), received a return product where it was found that the physical trimlines matches the digital trimlines.The upper arch has a slightly sharp edge on the lingual side of teeth #4-6 likely caused by the angle of the trimming robot and the flaring on teeth #4-5.The sharp edge is unnoticeable from a visual inspection, which is likely why it was not caught during final inspection.Both arches have good adaptation and no other defects.Probable cause: popping and cutting - operation.Clinical evaluation: this extent of an adverse reaction to wearing the aligners, even the remade ones, is a moderate medical risk to the patient.The patient should not wear the aligners.Regulatory evaluation: the patient presents with an ulceration on the tongue.While it is expected that such an injury would resolve without medical intervention upon cessation of treatment, the patient did seek medical treatment.Because this event resulted in medical intervention, it meets the criteria for adverse event reporting.

Event Description

Provider: hello there, i'm reporting a second injury for my patient#: (b)(6), which is even larger than the first injury.The patient had to seek medical attention today as the ulcer is extremely painful.This is aligner #1 and this is the second batch.She had a previous injury last time.She has decided to discontinue clear correct as per her md.I am very embarrassed this time and have no excuse for this.I'm not sure why we're getting so many injuries these days.Please send me a shipping slip, i will be sending the aligners back for qa to have a look at it, and can we process a refund for the patient? she is discontinuing her treatment.

• 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: 10819940
• MDR Text Key: 216202166
• Report Number: 3007130440-2020-00004
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: D865REF00011
• UDI-Public: +D865REF00011/$$522075269975/16D20200916
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/16/2022
• Device Model Number: Aligner (Single-Layer)
• Device Catalogue Number: REF-01
• Device Lot Number: 269975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2020
• 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: 22 YR