2026 data FDA MAUDE openFDA FDA Class II

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

reports

What this shows Aligner, Sequential carries 18,498 MAUDE reports, ranked #148 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 15,801 (85.4%)
Malfunction 2,600 (14.1%)
Other 90 (0.5%)
6 (0.0%)
Death 1 (0.0%)

Patient Outcomes

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

Required Intervention 6,471 (28.4%)
5,796 (25.4%)
Other 3,989 (17.5%)
Disability 2,055 (9.0%)
R 1,538 (6.7%)
O 1,448 (6.4%)
S 1,250 (5.5%)
Life Threatening 66 (0.3%)
Hospitalization 60 (0.3%)
C 48 (0.2%)
Congenital Anomaly 46 (0.2%)
H 15 (0.1%)
L 11 (0.0%)

Top Product Problems

Patient-Device Incompatibility 10,015
Sharp Edges 4,476
Device Appears to Trigger Rejection 2,125
Adverse Event Without Identified Device or Use Problem 1,943
Defective Device 1,681
Inadequacy of Device Shape and/or Size 1,163
Lack of Effect 419
Structural Problem 416
Appropriate Device Problem Term/Code Not Available 407
Unintended Movement 382
Insufficient Device Problem Information 225
Patient Device Interaction Problem 153
Crack 66
Break 56
Pressure Problem 44
Fitting Problem 42
Biocompatibility 22
Therapeutic or Diagnostic Output Failure 20
Improper or Incorrect Procedure or Method 17
Unexpected Therapeutic Results 16

Yearly Trend

06
2006: 1
07
2007: 1
08
2008: 5
09
2009: 2
10
2010: 11
11
2011: 59
12
2012: 24
13
2013: 28
14
2014: 27
15
2015: 43
16
2016: 41
17
2017: 47
18
2018: 67
19
2019: 127
20
2020: 175
21
2021: 929
22
2022: 605
23
2023: 433
24
2024: 8,992
25
2025: 4,578
26
2026: 2,303

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

17,615 (95.2%)
I 730 (3.9%)
NO INFORMATION 151 (0.8%)
HOME 2 (0.0%)

Compare STRAIGHT SMILE, LLC vs STRAIGHT SMILE LLC →

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.

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.