MAUDE Adverse Event Report: CLEARCORRECT LLC CLEAR CORRECT; ALIGNER, SEQUENTIAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Vertigo (2134); Joint Dislocation (2374); Unspecified Nervous System Problem (4426)

Event Date 12/15/2019

Event Type  Injury  

Event Description

An orthodontist approached me several times while he was treating my daughter with braces suggesting i get my teeth fixed.He then did an evaluation and asked if i would like treatment with braces or clear correct.I said, "you are the orthodontist given the condition of my teeth what do you suggest?" he advised clear correct to treat my teeth.Throughout treatment i complained about pain, disorientation, loss of bite and severe asymmetry the dr.Constantly said, "i will fix it" i went several orthodontists and was confirmed my teeth and jaw were in need of orthodontic braces and severally moved at year 2 of use of the device.My jaw was being held in position by muscles on both sides of my body while my jaw was severally dislocated.The issue caused neurological issues, back displacement, disorientation, vertigo, pain, the inability to eat, time out of work.The damage has caused medical treatment amongst an array of providers for all the problems that occurred.Fda safety report id# (b)(4).

• Brand Name: CLEAR CORRECT
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): CLEARCORRECT LLC
• MDR Report Key: 15543456
• MDR Text Key: 301257163
• Report Number: MW5112428
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White