Aligner, Sequential
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §872.5470 (Dental panel).
FDA MAUDE casebook
openFDA event book Aligner, Sequential MID-BOOK · MAUDE
#148 of 1000 · 18,498 reports · 2006–2026
- BOOK 18,498 reports
- RANK #148 of 1000
- DEATH 1 death-typed
- INJ 15,801 injury-typed
- MALF 2,600 malfunction
- SPAN 2006–2026
- PEAK 2024: 8,992
- PHOTO Device
Nearest event-volume peer: Device, Incontinence, Mechanical/Hydraulic (199 report gap)
Aligner, Sequential sits #148 of 1000 among tracked device types with 18,498 MAUDE reports spanning 2006–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Injury-coded reports run above the device-type norm
Aligner, Sequential carries 85.4% INJURY-coded reports, 55.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 85.4% corpus 30.3% · above corpus mean (+55.1 pp)
- MALF 14.1% corpus 64.8% · below corpus mean (-50.8 pp)
Lead product-problem code Patient-Device Incompatibility is 42% of coded problems · Lead manufacturer STRAIGHT SMILE, LLC accounts for 66% of manufacturer-tagged reports · Top event location is 95% of location-tagged rows .
Aligner, Sequential in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Aligner (this)
Aligner, Sequential
18,498 reports
- Device
Device, Incontinence, Mechanical/Hydraulic
18,299 reports
- Phakic Toric…
Phakic Toric Intraocular Lens
18,233 reports
- Motor
Motor, Surgical Instrument, Ac-Powered
18,194 reports
- Immunoassay M…
Immunoassay Method, Troponin Subunit
18,095 reports
- Humidifier
Humidifier, Respiratory Gas, (Direct Patient Interface)
18,072 reports
What this shows Aligner, Sequential carries 18,498 MAUDE reports, ranked #148 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (4,578) held close to the prior two-year average of 4,713.
Related Entities for Aligner, Sequential
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Aligner, Sequential: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (18,498 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Aligner, Sequential are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Aligner, Sequential; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.