MAUDE Adverse Event Report: PROSOMNUS SLEEP TECHNOLOGIES PROSOMNUS [CA] SLEEP AND SNORE DEVICE; INTRAORAL APPLIANCE FOR SNORING AND OBSTRUCTIVE SLEEP APNEA

Model Number	CA
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After investigation, the scan sent by the doctor was not accurate due to a bad capture.A dimentional distortion of -0.1 mm was found on the original scan leading to a tight fit on the incisors.The device fitted the initial models without resistance.
Event or Problem Description
The device was too tight on try in.The incisal edge of tooth #8 was fractured.

• Brand Name: PROSOMNUS [CA] SLEEP AND SNORE DEVICE
• Common Device Name: INTRAORAL APPLIANCE FOR SNORING AND OBSTRUCTIVE SLEEP APNEA
• Manufacturer (Section D): PROSOMNUS SLEEP TECHNOLOGIES; 5860 west las positas blvd.; suite 25; pleasanton CA 94588
• Manufacturer (Section G): PROSOMNUS SLEEP TECHNOLOGIES; 5860 west las positas blvd; suite 25; pleasanton CA 94588
• Manufacturer Contact: divya mavalli ; 5860 west las positas blvd; suite 25; pleasanton, CA 94588 ; 9253077069
• MDR Report Key: 14651872
• Report Number: 3013116677-2022-00001
• Device Sequence Number: 5693404
• Product Code: LRK
• UDI-Device Identifier: 00863039000409
• UDI-Public: (01)00863039000409(11)220322
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K172859
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 06/10/2022

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
• Operator of Device: Health Professional
• Device Model Number: CA
• Device Catalogue Number: 1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• 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: Required Intervention
• Patient Sex: Male