FDA Adverse Event
Malfunction
Summary report: N
BYTE NIGHT ALIGNERS
MDR report key: 20571154
·
Received October 30, 2024
Report
- Report Number
- 3014845255-2023-01022
- Event Type
- Malfunction
- Date Received
- October 30, 2024
- Report Date
- October 25, 2024
- Manufacturer
- STRAIGHT SMILE, LLC
- Product Code
- NXC
- UDI-DI
- 00850017524170
- PMA / PMN Number
- K180346
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS AND HARMONIZATION MADE TO THE COMPANY'S COMPLAINT HANDLING PROCESSES. THERE IS NO CHANGE TO DEVICE PERFORMANCE OR TO THE DEVICE RISK PROFILE. A CAPA (2023-487) HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. THIS RETROSPECTIVE REVIEW INCLUDES THE DATE RANGE OF 05/17/2021 THROUGH 05/31/2024.
Description of Event or Problem · 0
CUSTOMER REPORTS ALIGNERS ARE CUTTING GUMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1962391 | BYTE NIGHT ALIGNERS | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE, LLC | NBYTE TRAY | NA | 00850017524170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |