FDA Adverse Event
Malfunction
Summary report: N
ENDSNORZ SLEEP APPLIANCE (SILENT NITE 3D)
MDR report key: 25285762
·
Received May 26, 2026
Report
- Report Number
- 3011649314-2026-00823
- Event Type
- Malfunction
- Date Received
- May 26, 2026
- Report Date
- May 26, 2026
- Manufacturer
- PRISMATIK DENTALCRAFT, INC.
- Product Code
- LRK
- PMA / PMN Number
- K211069
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED FROM THE HEALTHCARE PROVIDER. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE PROBABLE ROOT CAUSE OF THE EVENT HAS NOT BEEN IDENTIFIED. SHOULD THE DEVICE BE RETURNED, AN INVESTIGATION WILL BE CONDUCTED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE CONCLUSION. MANUFACTURER INTERNAL REFERENCE NUMBER: (B)(4).
Description of Event or Problem · 0
A HEALTHCARE PROFESSIONAL REPORTED THAT A SILENT NITE 3D SLEEP APPLIANCE HAD BROKEN RIGHT ANCHOR ON THE UPPER ARCH. EVENT WAS REPORTED TO THE DENTAL OFFICE LOCATED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73910 | ENDSNORZ SLEEP APPLIANCE (SILENT NITE 3D) | SLEEP APPLIANCE | LRK | PRISMATIK DENTALCRAFT, INC. | MA-PC-SD-OP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |