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

Model Number	Retainer
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clearcorrect findings: a review of the lower digital scan and the start of treatment patient photos received on december 3, 2020 shows a chip at tooth 24 where the customer is describing.Clinical evaluation: the primary complaint is that tooth #24 was chipped and required restoration.Review of the records shows that this tooth is intact, however they also show that teeth #23 and #25 show signs of incisal edge wear.This patient has a worn dentition as evidenced by the incisal edge wear on several teeth.In essence, the enamel and dentin is crumbling away.In my opinion, the reason for the mifl restoration on 24 is related to the worn dentition vs the aligner.As an additional note, if tooth structure comes off with aligner wear, it is most likely compromised to begin with.
Event or Problem Description
The customer's office called in and stated the lower arch retainer for case# (b)(4) is too tight on the patient.Upon removal, the lower retainer broke a tooth.Tooth #24 was chipped on the mesial, facial, and lingual.The provider uses an outie tool to remove the retainer from the lower arch.The provider repaired the tooth immediately.

• Brand Name: CLEARCORRECT
• Common Device Name: 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: raquel brown ; 21 cypress blvd; round rock, TX 78665 ; 8883313233
• MDR Report Key: 15635472
• Report Number: 3007130440-2022-00008
• Device Sequence Number: 5810577
• Product Code: NXC
• UDI-Device Identifier: D865REF00041
• UDI-Public: +D865REF00041/$$52405612406555/16D20220826
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/19/2022

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
• Device Expiration Date: 02/26/2024
• Device Model Number: Retainer
• Device Catalogue Number: REF-04
• Device Lot Number: 3189995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female