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

Model Number	1309
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The scan sent by the doctor to prosomnus seemed to be distored as the device was designed around the files received.The finished device passed the prosomnus quality standard at final quality control.The doctor also mentioned that they extensively ground the arch to try making it fit which is another indication that the records received were not accurate.The device broke during the adjustment due to the extent of the distortion.The patient had a crown made to replace the chipped tooth and a new device has been made on the new scan received.
Event or Problem Description
Patient's tooth #7 chipped off during her delivery appointment.The doctor reported that she tried to adjust the tray, but it broke in half in the #7 area.

• 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
• Manufacturer (Section G): PROSOMNUS SLEEP TECHNOLOGIES; 5860 west las positas blvd; pleasanton CA 94588
• Manufacturer Contact: divya mavalli ; 5860 west las positas blvd.; suite 25; pleasanton, CA 94588 ; 9253077069
• MDR Report Key: 14682758
• Report Number: 3013116677-2022-00002
• Device Sequence Number: 4675104
• Product Code: LRK
• UDI-Device Identifier: 00863039000416
• UDI-Public: (01)00863039000416(11)220426
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/14/2022

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: 1309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• 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: Female