2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Aligner, Sequential MID-BOOK · MAUDE

#157 of 1000 · 16,486 reports · 2006–2026

  • BOOK 16,486 reports
  • RANK #157 of 1000
  • DEATH 1 death-typed
  • INJ 13,802 injury-typed
  • MALF 2,587 malfunction
  • SPAN 2006–2026
  • PEAK 2024: 8,992
  • PHOTO Catheter, Urological

Nearest event-volume peer: Catheter, Urological (13 report gap)

Aligner, Sequential sits #157 of 1000 among tracked device types with 16,486 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 83.7% corpus 30.4% · above corpus mean (+53.3 pp)
  • MALF 15.7% corpus 64.5% · below corpus mean (-48.8 pp)

Lead product-problem code Patient-Device Incompatibility is 54% of coded problems · Lead manufacturer STRAIGHT SMILE, LLC accounts for 75% 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 16,486 MAUDE reports, ranked #157 of 1000.

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

Event Types

Injury 13,802 (83.7%)
Malfunction 2,587 (15.7%)
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.

5,782 (33.2%)
Required Intervention 5,650 (32.5%)
Other 3,388 (19.5%)
Disability 1,462 (8.4%)
R 417 (2.4%)
O 350 (2.0%)
S 132 (0.8%)
Life Threatening 64 (0.4%)
Hospitalization 58 (0.3%)
Congenital Anomaly 43 (0.2%)
C 41 (0.2%)
H 14 (0.1%)
L 10 (0.1%)

Top Product Problems

Patient-Device Incompatibility 9,784
Sharp Edges 2,771
Adverse Event Without Identified Device or Use Problem 1,880
Inadequacy of Device Shape and/or Size 1,161
Device Appears to Trigger Rejection 451
Lack of Effect 419
Structural Problem 415
Appropriate Term/Code Not Available 355
Unintended Movement 349
Insufficient Information 159
Patient Device Interaction Problem 139
Crack 65
Break 55
Pressure Problem 44
Fitting Problem 42
Therapeutic or Diagnostic Output Failure 20
Biocompatibility 16
Improper or Incorrect Procedure or Method 16
Unexpected Therapeutic Results 15
Product Quality Problem 12

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: 291

Related Entities for Aligner, Sequential

Top Manufacturers

Event Locations

15,603 (94.6%)
I 730 (4.4%)
NO INFORMATION 151 (0.9%)
HOME 2 (0.0%)

Compare STRAIGHT SMILE, LLC vs STRAIGHT SMILE LLC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Aligner, Sequential, both 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.