MAUDE Adverse Event Report: CLEARCORRECT LLC CLEARCORRECT SYSTEM / ALIGNERS; 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	Tooth Fracture (2428)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the case shows the provider was having difficulty with the teeth tracking as they should.Replacements were requested for phase 1 steps 1-2 upper on (b)(6) 2020.Replacements were requested for phase 1 steps 1-2 upper and lower on (b)(6) 2020.Replacements were requested for phase 1 steps 1-5 upper on (b)(6) 2020.A review of the patient submission at the beginning of treatment shows stress fractures to tooth 24 and poor hygiene which can contribute to the broken tooth.Clinical evaluation: starting treatment photos show that the arch was already in a state of decline.Failing restoration on the tooth caused the browning in the location of damage.Browning could be due to years of failed restoration seepage.Damage of the teeth may be more related to the decline of the dentition.Other than that assessment, there does not appear to be a medical risk associated with the complaint.A request for return of the product was submitted to the provider but product has not yet been received.
Event or Problem Description
The doctor called and said she had a lot of trouble with the case.The teeth are not tracking as hoped.She resorted to using 2 upper trays per step.On (b)(6), she inserted tray 4 and then that night the patient took the tray out and the tooth broke.On (b)(6) 2020, a revision was submitted.The rx notes show: "tooth #24 broke from the force of the tray during removal of tray #4.Upper tray #4 is not well seated in anterior area.There is a gap between the tray and his incisal edges.I have called repeatedly for help on this case and tried the suggestions and nothing is working.I opted to take new impressions to start over.Please slow down the movement (more trays with less movement between steps).He is an older patient and maxillary teeth are not moving well.".

• Brand Name: CLEARCORRECT SYSTEM / ALIGNERS
• Common Device Name: CLEAR PLASTIC ORTHODONTIC ALIGNER
• Manufacturer (Section D): CLEARCORRECT LLC; 21 cypress blvd; round rock, tx
• MDR Report Key: 10457238
• Report Number: 3007130440-2020-00001
• Device Sequence Number: 3344800
• Product Code: NXC
• UDI-Device Identifier: D865REF00011
• UDI-Public: +D865REF00011/$$523033234825/16D20200202
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113618
• Number of Events Summarized: 1
• Summary Report (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): 08/14/2020

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: 08/07/2021
• Device Model Number: Aligner (Single-Layer)
• Device Catalogue Number: REF-01
• Device Lot Number: 234825
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR