MAUDE Adverse Event Report: STRAUMANN /CLEARCORRECT LLC CLEARCORRECT; ALIGNER, SEQUENTIAL

Model Number 289453

Device Problem Off-Label Use (1494)

Patient Problems Pain (1994); Deformity/ Disfigurement (2360); Joint Dislocation (2374); Unspecified Nervous System Problem (4426)

Event Type  Injury  

Event Description

I used clear correct clear aligners prescribed to me by an orthodontist in 2018-2020.I discontinued use due to severe pain, all while being seen monthly by the orthodontist who prescribed the aligners.I sought advice from 8 other orthodontist after severe pain and health issues including the inability to chew or eat.It was confirmed that my jaw was dislocated.The device used to my dismay had manipulated my muscles that were holding a misplaced severely dislocated jaw (40% overjet on my right side) due to the aligners.I was a victim to an off label use to a provider and product.I am still currently being treated to correct the issue.This problem impacted my central nerves, back, posture, personal life due to the inability to chew or eat, along w disfigurement.Dates of use: (b)(6) 2018 - (b)(6) 2020.Fda safety report id # (b)(4).

• Brand Name: CLEARCORRECT
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): STRAUMANN /CLEARCORRECT LLC
• MDR Report Key: 15348655
• MDR Text Key: 299306263
• Report Number: MW5111854
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 289453
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Sex: Female
• Patient Weight: 41 KG
• Patient Race: White