MAUDE Adverse Event Report: SICAT GMBH & CO. KG SICAT OPTISLEEP; INTRAORAL DEVICE FOR SNORING AND OBSTRUCTIVE SLEEP APNEA

Catalog Number 10401

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

The analysis gives strong indication that the root cause of the event is insufficient retention of the sicat optisleep device.During sleep the mandibular part of the device dislodged from the correct position on the mandible.Simulations show that forces from biting on the device in dislodged position accurately reproduce the pattern of the fracture of the device.The dentist recommended to report the event.He thinks, that if a similar event were to recur, small pieces of a fractured device might be aspirated, possibly resulting in a serious injury.

Event Description

The reporting dentist reports that a sicat optisleep anti-snoring device broke while the patient was sleeping.At the distolingual edge of the optisleep device a piece of about 2 x 5 mm broke off.The patient did not swallow or aspirate any pieces.

• Brand Name: SICAT OPTISLEEP
• Type of Device: INTRAORAL DEVICE FOR SNORING AND OBSTRUCTIVE SLEEP APNEA
• Manufacturer (Section D): SICAT GMBH & CO. KG; brunnenallee 6; bonn, nrw 53177 ; GM 53177
• Manufacturer Contact: manfred breuer ; brunnenallee 6; bonn, nrw 53177 ; GM 53177 ; 228854697
• MDR Report Key: 6600319
• MDR Text Key: 76513625
• Report Number: 3006098230-2017-00005
• Device Sequence Number: 1
• Product Code: LRK
• UDI-Device Identifier: D776104010
• UDI-Public: +D776104010/16D20170125Q
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153291
• 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: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: 10401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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 Age: 31 YR
• Patient Weight: 77