FDA Adverse Event
Malfunction
Summary report: N
SILENT NITE 3D ONE PIECE
MDR report key: 24906042
·
Received April 16, 2026
Report
- Report Number
- 3011649314-2026-00612
- Event Type
- Malfunction
- Date Received
- April 16, 2026
- Report Date
- May 22, 2026
- Manufacturer
- PRISMATIK DENTALCRAFT, INC.
- Product Code
- LRK
- PMA / PMN Number
- K211069
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. THE EVALUATION OF THE DEVICE IS PENDING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem · 0
ON 04/07/2026, A HEALTHCARE PROFESSIONAL REPORTED THAT THE ANCHOR BROKE ON THE UPPER ARCH OF THE APPLIANCE. NO PERMANENT INJURIES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171858 | SILENT NITE 3D ONE PIECE | ANTI SNORING NIGHTGUARD | LRK | PRISMATIK DENTALCRAFT, INC. | MA-PC-SD-OP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |