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2026 data FDA MAUDE openFDA

File, Pulp Canal, Endodontic

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.

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FDA MAUDE casebook

openFDA event book File, Pulp Canal, Endodontic LIGHT-BOOK · MAUDE

#358 of 1000 · 3,734 reports · 1996–2026

  • BOOK 3,734 reports
  • RANK #358 of 1000
  • DEATH 0 death-typed
  • INJ 213 injury-typed
  • MALF 3,516 malfunction
  • SPAN 1996–2026
  • PEAK 2019: 468
  • PHOTO Visual

Nearest event-volume peer: Visual, Pregnancy Hcg, Prescription Use (3 report gap)

File, Pulp Canal, Endodontic sits #358 of 1000 among tracked device types with 3,734 MAUDE reports spanning 1996–2026. 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 → · 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 5.7% corpus 30.4% · below corpus mean (-24.7 pp)
  • MALF 94.2% corpus 64.5% · above corpus mean (+29.7 pp)

Lead product-problem code Break is 89% of coded problems · Top event location is 60% of location-tagged rows .

File, Pulp Canal, Endodontic in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows File, Pulp Canal, Endodontic carries 3,734 MAUDE reports, ranked #358 of 1000.

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

Event Types

Malfunction 3,516 (94.2%)
Injury 213 (5.7%)
Other 3 (0.1%)
2 (0.1%)

Patient Outcomes

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

3,341 (89.1%)
Other 250 (6.7%)
Required Intervention 107 (2.9%)
Disability 36 (1.0%)
R 11 (0.3%)
S 3 (0.1%)

Top Product Problems

Break 2,746
Material Separation 101
Difficult to Remove 91
Entrapment of Device 59
Detachment of Device or Device Component 39
Material Fragmentation 12
Fracture 7
Detachment Of Device Component 6
Material Split, Cut or Torn 5
Adverse Event Without Identified Device or Use Problem 4
Material Integrity Problem 4
Use of Device Problem 4
Device Handling Problem 3
Appropriate Term/Code Not Available 2
Device Operates Differently Than Expected 2
Failure to Osseointegrate 2
Nonstandard Device 2
Patient Device Interaction Problem 2
Therapeutic or Diagnostic Output Failure 2
Defective Device 1

Yearly Trend

96
1996: 1
97
1997: 2
01
2001: 1
02
2002: 1
03
2003: 62
04
2004: 189
05
2005: 155
06
2006: 256
07
2007: 104
08
2008: 10
09
2009: 16
10
2010: 10
11
2011: 20
12
2012: 14
13
2013: 30
14
2014: 17
15
2015: 56
16
2016: 28
17
2017: 53
18
2018: 258
19
2019: 468
20
2020: 421
21
2021: 342
22
2022: 291
23
2023: 264
24
2024: 313
25
2025: 330
26
2026: 22

Related Entities for File, Pulp Canal, Endodontic

Event Locations

2,233 (59.8%)
I 1,468 (39.3%)
NO INFORMATION 11 (0.3%)
NOT APPLICABLE 9 (0.2%)
OTHER 8 (0.2%)
HOSPITAL 2 (0.1%)
OUTPATIENT TREATMENT FACILITY 2 (0.1%)
INVALID DATA 1 (0.0%)

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for File, Pulp Canal, Endodontic, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (3,734 here).

Visual, Pregnancy Hcg, Prescription Use 3,737 Covid-19 Multi-Analyte Antigen Device 3,713 Suture, Nonabsorbable, Silk 3,765 Artificial Heart 3,662

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for File, Pulp Canal, Endodontic 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 File, Pulp Canal, Endodontic; 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.