MAUDE Adverse Event Report: ALLESEE ORTHODONTIC APPLIANCES RED, WHITE AND BLUE ALIGNER

Model Number	3000-0004
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	06/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor alleged when the patient removed a tray of the red, white and blue aligner, a tooth was chipped.The patient will return for restoration of the tooth.

• Brand Name: RED, WHITE AND BLUE ALIGNER
• Common Device Name: ALIGNER
• Manufacturer (Section D): ALLESEE ORTHODONTIC APPLIANCES; 13931 spring street; sturtevant WI 53177
• MDR Report Key: 8769398
• Report Number: 2184045-2019-00001
• Device Sequence Number: 2374741
• Product Code: NXC
• UDI-Device Identifier: 00889989061901
• UDI-Public: (01)00889989061901(10)4649571
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K040874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2019

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: No Information
• Device Model Number: 3000-0004
• Device Lot Number: 4649571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/08/2019
• 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: Other
• Patient Age: 31 YR