MAUDE Adverse Event Report: PROSOMNUS SLEEP TECHNOLOGIES PROSOMNUS [IA] SLEEP AND SNORE DEVICE; MANDIBULAR ADVANCEMENT DEVICE

Model Number	1020
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	10/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacture date of the device indicates the device was out of warranty.Initial performance testing data reveals an extreme amount of force, either at once or repetitive, was required to dislodge or break-off any post.The patient was reported to brux and clench during sleep.This could be the probable cause for post breakage.Prosomnus replaced the patient's osa device with a newer model that has more flexibility and improved material and posts compared to the product involved in the incident.
Event or Problem Description
Prosomnus received a complaint from dentist reporting about a patient aspirating a broken piece of the device during use.Patient had to undergo endoscopy in emergency department to remove the broken fragment from the patient's right lung.Dentist also confirmed that there was no further complications to the patient due to this incident.Patient wants to continue the treatment with prosomnus device.

• Brand Name: PROSOMNUS [IA] SLEEP AND SNORE DEVICE
• Common Device Name: MANDIBULAR ADVANCEMENT DEVICE
• 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: kevin ramaiya ; 5860 west las positas blvd.; suite 25; pleasanton, CA 94588 ; 9253077069
• MDR Report Key: 15992887
• Report Number: 3013116677-2022-00003
• Device Sequence Number: 15004767
• Product Code: LRK
• UDI-Device Identifier: 00863039000416
• UDI-Public: (01)00863039000416(11)190807
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/15/2022

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: Lay User/Patient
• Device Model Number: 1020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2019
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female