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

Model Number 1309

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Tooth Fracture (2428)

Event Date 05/05/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 301750441
• Report Number: 3013116677-2022-00002
• Device Sequence Number: 1
• Product Code: LRK
• UDI-Device Identifier: 00863039000416
• UDI-Public: (01)00863039000416(11)220426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female