BYTE NIGHT ALIGNER
Report
- Report Number
- 3014845255-2024-01230
- Event Type
- Injury
- Date Received
- September 25, 2024
- Report Date
- September 25, 2024
- Manufacturer
- STRAIGHT SMILE , LLC
- Product Code
- NXC
- UDI-DI
- 00850017524170
- PMA / PMN Number
- K230199
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803.
WHILE USING A BYTE NIGHT ALIGNERS, PATIENT REPORTED THEY WERE EVALUATED FOR ORTHODONTIC NEEDS. THE ORTHODONTIST DIAGNOSIS: CLASS III TENDENCY RIGHT SIDE, CLASS II TENDENCY LEFT, THE UPPER FRONT TEETH ARE SLIGHTLY AHEAD OF THE LOWER FRONT TEETH 2MM, OVERBITE EXCESSIVE 60%, UPPER MIDLINE TO THE RIGHT OF CENTER, MILD RECESSION TOOTH #8, UPPER AND LOWER TEETH ARE CROWDED, CONSTRICTED UPPER AND LOWER ARCHES WITH RESULTING NARROW SMILE, BILATERAL CLICKING UPON OPENING. TREATMENT : CLEAR ALIGNERS - BRACELESS ORTHODONTICS, PROPEL - AN AT HOME REMOVABLE APPLIANCE THAT ACCELERATES TOOTH MOVEMENT UP TO 40% MAY BE USED IN CONJUNCTION WITH ORTHODONTIC TREATMENT, TOOTH COLORED ATTACHMENTS WILL BE BONDED TO SELECTED TEETH TO ENGAGE ALIGNERS, ELASTIC WEAR WILL BE REQUIRED DURING TREATMENT, ADDITIONAL ALIGNERS WILL BE NECESSARY TO ACHIEVE DESIRED RESULT, MAXILLARY AND MANDIBULAR RETAINERS TO MAINTAIN ORTHODONTIC CORRECTION, TREATMENT TIME APPROXIMATELY 12 MONTHS, CORRECT MALOCCLUSION (POOR BITE), LEVEL AND ALIGN TEETH AND ARCHES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1198399 | BYTE NIGHT ALIGNER | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE , LLC | NBTYE TRAY | 00850017524170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |