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

Catalog Number 1020

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

Patient Problem Tooth Fracture (2428)

Event Date 05/08/2019

Event Type  Injury  

Event Description

Dentist reported that patient's first molar with root canal and crown cracked due to stress on that tooth from the device.Upon further questioning, dentist reported that the patient required extraction of the first molar and an implant.Further investigation revealed that the second molar was not wrapped with the device, which may have added stress on the first molar causing the tooth to crack.

• Brand Name: PROSOMNUS [IA] DEVICE
• Type of Device: MICRO2 OBSTRUCTIVE SLEEP APNEA DEVICE
• Manufacturer (Section D): PROSOMNUS SLEEP TECHNOLOGIES; 5860 west laspositas blvd; suite 25; pleasanton CA 94588
• Manufacturer (Section G): PROSOMNUS SLEEP TECHNOLOGIES; 5860 west las positas blvd; suite 25; pleasanton CA 94588
• Manufacturer Contact: david kuhns ; 5860 west las positas blvd; suite 25; pleasanton, CA 94588 ; 8445375337
• MDR Report Key: 8674828
• MDR Text Key: 147194743
• Report Number: 3013116677-2019-00001
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/06/2019

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: Lay User/Patient
• Device Catalogue Number: 1020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2019
• Initial Date FDA Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention