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

Lot Number 1363202

Device Problem Insufficient Information (3190)

Patient Problem Subclinical Infection (2247)

Event Type  Injury  

Manufacturer Narrative

Initial findings: this is a follow up complaint to (b)(4).The hypothesis for (b)(4) was the incorrect device may have been packaged in the step 10 aligner bag.A photo of the affected device was received, but the device id was illegible.The tooth anatomy matched patient, but the dentition appears to be from a different step, possibly step 6.The step 10 device was reproduced to rule out packaging errors.The clinician stated they would back track the patient to step 9 and resume 10 later.The tracking information for the device shows it was delivered on (b)(6), 2023.The follow-up complaint states the tooth became abscessed and leaked pus.It is unclear if the tooth became abscessed during back tracking, resuming the affected step 10, or resuming replacement step 10.Clarification has been requested.The clinician stated the approved treatment plan did not have any movements on tooth 22 due to periodontal disease.However, the approved treatment setup shows significant movements were planned for tooth 22: · 1.61mm mesial translation.· 1.26mm buccal translation.· 3° mesial crown toque.· 11° mesial rotation.No intrusion was planned for tooth 22, and the customer did not state in the rx or instructions to avoid movement on tooth 22.Clinical evaluation: existing periodontal issues is a contraindication for orthodontic tooth movement.Numerous scientific studies demonstrate that attempts at orthodontic tooth movement in the presence of periodontal disease will exasperate the situation and lead to rapid bone loss, inflammation and tooth loss.The presence of pus and diagnosis of local abcess confirm the sequelae.Whether the potentially incorrect device was used is peripheral to this central issue.In other words, a healthy tooth is more than capable of withstanding an aligner that is out of step without long term consequence.

Event Description

Follow up to a previous complaint: according to the dentist, the aligner has put too much pressure on tooth 22.On the phone, the dentist mentioned that the tooth had existing periodontal issues, and should therefore, under no circumstances be intruded or extruded.However, step 10 started to intrude the tooth and put far too much pressure on it.The tooth is now abscessed and is ´leaking´ puss.

• 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: david jue ; 21 cypress blvd; round rock, TX 78665
• MDR Report Key: 18080482
• MDR Text Key: 327483928
• Report Number: 3007130440-2023-00007
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: D865REF00031
• UDI-Public: +D865REF00031/$$52432218085552/16D20230530
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Notification
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 1363202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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: 61 YR
• Patient Sex: Prefer Not To Disclose