PlainHospital

STRAIGHT SMILE, LLC

Manufacturer adverse-event records for STRAIGHT SMILE, LLC come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2020–2025 · mid-book · quiet Death-code · injury-heavy

Death-code intensity

STRAIGHT SMILE, LLC is quieter on Death-coded events

Death-coded event_type rows are 0 of 10,662 (0.00% · quiet tercile among 434 manufacturers). Absolute volume is mid-book.

What the Death-code reading shows for STRAIGHT SMILE, LLC

The standout signal for STRAIGHT SMILE, LLC is Death-code intensity: 0.00% of 10,662 reports (quiet tercile), while absolute volume is mid-book.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for STRAIGHT SMILE, LLC. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 3 device types, led in this extract by Injury at 8,327 (78.1% of event_type total). Peak single-year volume reaches 7,917 reports across 6 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

10,662
Total Reports
0
Event-type Death
8,327
Injury Reports
3
Device Types

Event Types

Injury 8,327 (78.1%)
Malfunction 2,335 (21.9%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

5,701 (53.0%)
Required Intervention 2,875 (26.7%)
Other 1,565 (14.5%)
Disability 474 (4.4%)
Congenital Anomaly 34 (0.3%)
R 32 (0.3%)
C 28 (0.3%)
S 24 (0.2%)
O 16 (0.1%)
Hospitalization 7 (0.1%)
Life Threatening 4 (0.0%)
H 3 (0.0%)

Devices (3)

Device Reports
Aligner, Sequential 10,150
Positioner, Tooth, Preformed 511
Orthodontic Vibratory Accessory 1

Yearly Trend

20
2020: 1
21
2021: 7
22
2022: 49
23
2023: 57
24
2024: 7,917
25
2025: 2,631

Read our methodology - how this data is sourced, computed, and verified.