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2026 data FDA MAUDE openFDA FDA Class I

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.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §872.4565 (Dental panel).

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FDA MAUDE casebook

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

#356 of 1000 · 3,925 reports · 1996–2026

  • BOOK 3,925 reports
  • RANK #356 of 1000
  • DEATH 0 death-typed
  • INJ 217 injury-typed
  • MALF 3,703 malfunction
  • SPAN 1996–2026
  • PEAK 2019: 468
  • PHOTO Transducer

Nearest event-volume peer: Transducer, Blood-Pressure, Extravascular (21 report gap)

File, Pulp Canal, Endodontic sits #356 of 1000 among tracked device types with 3,925 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 →

Malfunction reports run above the device-type norm

File, Pulp Canal, Endodontic carries 94.3% MALFUNCTION-coded reports, 29.5pp 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 5.5% corpus 30.3% · below corpus mean (-24.8 pp)
  • MALF 94.3% corpus 64.8% · above corpus mean (+29.5 pp)

Lead product-problem code Break is 67% of coded problems · Top event location is 62% 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 3,925 MAUDE reports, ranked #356 of 1000.

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

Event Types

Malfunction 3,703 (94.3%)
Injury 217 (5.5%)
Other 3 (0.1%)
2 (0.1%)

Patient Outcomes

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

3,503 (89.6%)
Other 250 (6.4%)
Required Intervention 107 (2.7%)
Disability 36 (0.9%)
R 11 (0.3%)
S 3 (0.1%)

Top Product Problems

Break 3,044
Material Separation 892
Device, or device fragments remain in patient 256
Difficult to Remove 108
Entrapment of Device 62
Detachment of Device or Device Component 40
Detachment Of Device Component 18
Material Fragmentation 14
Fracture 12
Device Or Device Fragments Location Unknown 11
Device, removal of (non-implant) 11
Tip breakage 9
Adverse Event Without Identified Device or Use Problem 5
Component Falling 5
Device Operates Differently Than Expected 5
Device remains implanted 5
Insufficient Device Problem Information 5
Material Integrity Problem 5
Material Split, Cut or Torn 5
Use of Device Problem 5

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: 213

Reports in 2025 (330) held close to the prior two-year average of 289.

Related Entities for File, Pulp Canal, Endodontic

Event Locations

2,424 (61.8%)
I 1,468 (37.4%)
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 a comparable report-volume footprint

File, Pulp Canal, Endodontic carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (3,925 here).

Transducer, Blood-Pressure, Extravascular 3,904 Transducer, Ultrasonic, Diagnostic 3,948 Prosthesis, Hip, Semi-Constrained 3,885 Suture, Nonabsorbable, Silk 3,979

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.