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

Model Number	Aligner (Single-Layer)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint handling specialist findings: findings: (document what was investigated) a review of case #(b)(4) shows the upper digital scan received on october 30, 2020 were properly scanned with no errors or distortions present.All protocols were followed during the cut and stage process.I'm currently waiting on the customer to send over the latest x-rays to add to the complaint and this portion of the investigation.The customer was contacted several times, unfortunately, there was no reply and no additional information was provided.Unable to determine the cause of the adverse event due to lack of information provided.Clinical assessment: the treatment setup shows that teeth #11 and #12 are moved only slight amounts (step 1 and the stage file shows we are translating tooth 11.01mm mesial,.11mm buccal,.22 degrees torque buccal, and rotating mesial.67 degrees.Tooth 12 is translating.10mm, buccal.05mm, extruding.08mm, and rotating mesial 1.5 degrees.) these parameters are well within the range of normal and customary orthodontic tooth movement.It is unlikely that the "irreversible pulpitis" in these teeth is related to aligner therapy.No radiographs were provided and the details of the supporting bone and tooth roots cannot be assessed.The photos provided are somewhat out of focus but seem to show clinical crowns that are non-carious and unrestored.As such, there is no definitive cause and effect that can be established.
Event or Problem Description
The customer (dentist) states the force to move the upper anterior teeth for case #(b)(4) was too strong causing irreversible pulpitis on tooth 11 and 12.Doctor had to perform root canal therapy on tooth 12.

• Brand Name: CLEARCORRECT SYSTEM
• Common Device Name: CLEAR PLASTIC ORTHODONTIC ALIGNER
• Manufacturer (Section D): CLEARCORRECT; 21 cypress blvd; round rock TX 78665
• MDR Report Key: 11815844
• Report Number: 3007130440-2021-00002
• Device Sequence Number: 3224368
• Product Code: NXC
• UDI-Device Identifier: D865REF00011
• UDI-Public: +D865REF00011/$$522131281467/16D20201111
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/11/2022
• Device Model Number: Aligner (Single-Layer)
• Device Catalogue Number: REF-01
• Device Lot Number: 281467
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR