MAUDE Adverse Event Report: PROSOMNUS SLEEP TECHNOLOGIES PROSOMNUS EVO SLEEP AND SNORE DEVICE; MANDIBULAR ADVANCEMENT DEVICE

Model Number	1450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tooth Fracture (2428); Bruxism (4427)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of device history records including production related records indicates no discrepancy or product related problem.The design file was also reviewed and the device was manufactured according to specification and prescription.The finished device passed the prosomnus quality standard at final quality control for fit and finish.The possibility exists that the patient's pre-existing condition of bruxism and previous root canal may have contributed to the tooth fracture in combination with device use.The prescribing dentist office advised they had communicated via informed consent records that there can be issues with device use.Our product related documentation, user manual & instructions for use, contain warnings of tooth movement, changes in dental occlusion, gingival or dental soreness.The same prescribing dentist had adjusted the prosomnus evo sleep and snore device to a more passive fit after the placement of the dental implant.The patient is currently using the same device, prosomnus evo sleep and snore device, which was provided to him earlier.
Event or Problem Description
Prosomnus sleep technologies was made aware of an incident of root canaled tooth breakage on (b)(6) 2025 that occurred on (b)(6) 2025.Patient broke tooth # 9, presumably at the gumline, due to excess pressure the day after device delivery.He went to his general dentist and it [tooth # 9] was extracted and an implant was placed.

• Brand Name: PROSOMNUS EVO SLEEP AND SNORE DEVICE
• Common Device Name: MANDIBULAR ADVANCEMENT DEVICE
• Manufacturer (Section D): PROSOMNUS SLEEP TECHNOLOGIES; 5675 gibraltar drive; pleasanton CA 94588
• Manufacturer Contact: divya mavalli ; 5675 gibraltar drive; pleasanton, CA 94588 ; 9253077069
• MDR Report Key: 21612792
• Report Number: 3013116677-2025-00001
• Device Sequence Number: 12678090
• Product Code: LRK
• UDI-Device Identifier: 00863039000485
• UDI-Public: (01)00863039000485(11)241219
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K202529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Modification/Adjustment,Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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: 1450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male