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

Catalog Number	10401
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: INTRAORAL DEVICE FOR SNORING AND OBSTRUCTIVE SLEEP APNEA
• Manufacturer (Section D): SICAT GMBH & CO. KG; brunnenallee 6; bonn, nrw 53177 ; GM 53177
• MDR Report Key: 6600319
• Report Number: 3006098230-2017-00005
• Device Sequence Number: 18973408
• Product Code: LRK
• UDI-Device Identifier: D776104010
• UDI-Public: +D776104010/16D20170125Q
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Dentist
• Device Catalogue Number: 10401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2017
• Initial Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 77