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

Model Number Aligner (Multi-layer)

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Difficulty Chewing (4522)

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

Clearcorrect findings: a review of the case ledger shows numerous delays/extended timeframes during treatment.The initial impressions were submitted on march 8, 2019 and a setup was sent on (b)(6) 2019.The version 2 setup was approved on (b)(6) 2019.The 12-step phase 1 shipped on june 15, 2019 with a two-week wear schedule, the patient should have completed the treatment by late (b)(6) 2019.A revision was submitted on february 21.2020 2020; the version 3 treatment was approved on (b)(6) 2020, and the 5-step phase 2 shipped in march 15, 2020.Another revision was submitted on june 25, 2020, but scans were not received until august 19, 2020 and the version 4 treatment was not approved until (b)(6) 2020.The 5-step phase 3 was shipped on september 15, 2020.The treatment should have completed by late (b)(6) 2020, but the last revision was not submitted until march 31, 2021, and the records were received on april 7, 2021.The version 5 setup was approved on (b)(6) 2021, and the 5-step phase 4 was shipped on may 21, 2021.The treatment should have completed by august of 2021, but the retainer based on existing records was not ordered until (b)(6) 2021.A comparison of the last step from the phase 3 (step 23) to the scans received on april 7, 2021 shows signs of tracking issues and incomplete movements.Unable to determine any treatment planning contributing factors that would lead to tracking issues.All treatment planning protocols and prescriptions were followed.Clinical evaluation: the etiologies of temporomandibular joint dysfunction (tmd) encompass a broad range of factors which include occlusal abnormalities, orthodontic treatment, bruxism and orthopedic instability, macrotrauma and microtrauma, joint laxity and exogenous estrogen.Psychological factors such as stress, mental tension, anxiety or depression can cause tmd.Within the structures of the temporomandibular joint are hard and soft tissues which may be affected.It is noted that the patient had seen a specialist who diagnosed myofascial pain and internal derangement and was managed with a splint.Neither of these diagnosis are reported to be associated with aligner therapy.As such, it is most likely that the patient's symptoms are coincident with aligner therapy as opposed to the result of it.Regulatory evaluation: this case is related to treatment provided by private-label customer candid; as legal manufacturer, (b)(4) is responsible for adverse event reporting.We are assessing this event as we are the physical manufacturer of the devices used in this case, so this is relevant to our post-market surveillance activities.Based upon our investigation, there appears to have been patient compliance issues throughout this case.A number of revisions were needed to complete the treatment.Ultimately a retainer was ordered based upon the final treatment step; ordering a retainer is an indication that the patient and clinician were satisfied with the outcome of aligner therapy.The retainer was ordered (b)(6) 2021.The information provided to clearcorrect by candid indicates that the patient first complained about their "bite being off" in (b)(6) 2021 (this coincides with receipt of the phase 2 devices).The patient reported to candid that they had seen a specialist on (b)(6)2021 who had prescribed a jaw splint.Candid did not report this event to clearcorrect until (b)(6) 2022.It is unclear whether the patient may have had issues with tmj prior to the start of treatment.Because this event occurred during the time of aligner treatment, it is possible that the treatment was a contributing factor.The patient did seek medical treatment to address the "bite being off." the patient was prescribed a jaw splint, which is a medical intervention in this case.Based upon these details, this event does meet the criteria for adverse event reporting.

Event Description

Per the candid co, the patient reports tmj issues, and that they've seen a specialist that prescribed a jaw splint.The patient first reported their bite being off in (b)(6) 2021, during treatment.However, bite issues are a known and disclosed side effect of all orthodontic treatment.On (b)(6) 2021, the patient reported that they'd seen the jaw specialist and required a jaw splint.A product return is not possible, because the patient alleges that treatment, overall, has caused this issue, and not a specific step, arch, or device.There are no reports of the device being altered and no photos of the devices.

• Brand Name: CLEARCORRECT
• 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 ; 8883313233
• MDR Report Key: 15638794
• MDR Text Key: 302124794
• Report Number: 3007130440-2022-00010
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: D865REF00031
• UDI-Public: +D865REF00031/$$522074269534/16D20200915
• 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: Company Representative
• Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/15/2022
• Device Model Number: Aligner (Multi-layer)
• Device Catalogue Number: REF-03
• Device Lot Number: 269534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male