MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. DAYBREAK; ANTI-SNORING

Model Number	DBK-DEV-001
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Office reported button broke while patient was wearing the device, no other information was provided.
Additional Manufacturer Narrative
The device will not be returned.A non-visual investigation will be performed and a supplemental report will be submitted.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction: g1.
Additional Manufacturer Narrative
Case (b)(4).Manufacturer reference: (b)(4).Additional information: a1, d4 (model #, catalog#), e1, g3.Correction: d1, d4 s.N.E2 (no), e3, g1, g2.
Additional Manufacturer Narrative
A non-visual investigation has been completed and the results are as follows: dhr results: dhr was reviewed by daybreak.Stock product reviewed results: no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results: the reported product has not been returned to the complaint handling team to date therefore an analysis of the physical product could not be performed.Root cause description: the root cause could not be determined.A potential root cause could be due to an incomplete curing which may have caused the anchor to break off.The manufacturer internal reference number is: (b)(4).

• Brand Name: DAYBREAK
• Common Device Name: ANTI-SNORING
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer Contact: shelly gallup ; 2144 michelson drive; irvine, CA 92612 ; 9492223590
• MDR Report Key: 22667326
• Report Number: 3011649314-2025-00859
• Device Sequence Number: 3701987
• Product Code: LRK
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/18/2026

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: Lay User/Patient
• Device Model Number: DBK-DEV-001
• Device Catalogue Number: DBK-DEV-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: Not provided; 11/10/2025; 03/13/2026
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/19/2025; 11/14/2025; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 109 KG