FDA Adverse Event
Malfunction
Summary report: N
BYTE NIGHT ALIGNERS
MDR report key: 20893451
·
Received December 10, 2024
Report
- Report Number
- 3014845255-2024-04715
- Event Type
- Malfunction
- Date Received
- December 10, 2024
- Report Date
- October 14, 2025
- Manufacturer
- STRAIGHT SMILE, LLC
- Product Code
- NXC
- UDI-DI
- 00850017524170
- PMA / PMN Number
- K230199
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.
Additional Manufacturer Narrative · 0
THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803.
Description of Event or Problem · 0
PATIENT REPORTS THE BOTTOM TEETH DO NOT FEEL LIKE THEY ARE MOVING PER TREATMENT PLAN. THE TEETH AND GUMS ARE SENSITIVE INTERMITTENTLY THROUGHOUT THE DAY AND THE TEETH FEEL LOOSE ON OCCASION. PER BYTE CST (CLINICAL SUPPORT TEAM) THE PATIENT WAS EDUCATED ON MOBILITY AND TOOTH SENSITIVITY ARE WNL (WITHIN NORMAL LIMITS) OF TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2533225 | BYTE NIGHT ALIGNERS | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE, LLC | NBYTE TRAY | 00850017524170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |