MAUDE Adverse Event Report: ALLESEE ORTHODONTIC APPLIANCES BILATERAL DISTAL JET

Catalog Number	3000-0090
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor alleges a bilateral distal jet appliance came apart in the patient's mouth.During removal of the appliance, the patient swallowed the spring.The patient confirmed the spring passed naturally without incident.

• Brand Name: BILATERAL DISTAL JET
• Common Device Name: DISTAL JET
• Manufacturer (Section D): ALLESEE ORTHODONTIC APPLIANCES; 13931 spring street; sturtevant WI 53177
• Manufacturer (Section G): ALLESEE ORTHODONTIC APPLIANCES; 13931 spring street; sturtevant WI 53177
• Manufacturer Contact: suzanne simpkins ; 13931 spring street; sturtevant, WI 53177 ; 2628861050
• MDR Report Key: 20021099
• Report Number: 2184045-2024-00002
• Device Sequence Number: 8600949
• Product Code: DYJ
• UDI-Device Identifier: 00889989088014
• UDI-Public: 00889989088014
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3000-0090
• Device Lot Number: 32632146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 10 YR
• Patient Sex: Female