MAUDE Adverse Event Report: PROSOMNUS SLEEP TECHNOLOGIES PROSOMNUS [IA] SLEEP AND SNORE DEVICE; MICRO2 OBSTRUCTIVE SLEEP APNEA DEVICE

Model Number	IA Monogram
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Dentist reported that the patient broke tooth #14, which had a two surface composite in it while wearing the device.The crown was cemented and the dentist temporarily adjusted the device and reported that it worked fairly well.However, the patient broke teeth #5 and #23 soon after.Upon further questioning, the dentist reported that the crown was cemented and another oral device was made for the patient.The patient did not need any medical attention.

• Brand Name: PROSOMNUS [IA] SLEEP AND SNORE DEVICE
• Common Device Name: MICRO2 OBSTRUCTIVE SLEEP APNEA DEVICE
• Manufacturer (Section D): PROSOMNUS SLEEP TECHNOLOGIES; 5860 west las positas blvd; suite 25; pleasanton CA 94588
• MDR Report Key: 10589316
• Report Number: 3013116677-2020-00001
• Device Sequence Number: 19497141
• Product Code: LRK
• UDI-Device Identifier: 00863039000416
• UDI-Public: 00863039000416
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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: Lay User/Patient
• Device Model Number: IA Monogram
• Device Catalogue Number: 1020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/25/2020
• 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: Required Intervention