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2026 data FDA MAUDE openFDA FDA Class II

Resin, Root Canal Filling

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 §872.3820 (Dental panel).

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FDA MAUDE casebook

openFDA event book Resin, Root Canal Filling LIGHT-BOOK · MAUDE

#775 of 1000 · 703 reports · 1997–2026

  • BOOK 703 reports
  • RANK #775 of 1000
  • DEATH 0 death-typed
  • INJ 657 injury-typed
  • MALF 41 malfunction
  • SPAN 1997–2026
  • PEAK 2014: 421
  • PHOTO Coronary Covered Stent

Nearest event-volume peer: Coronary Covered Stent (1 report gap)

Resin, Root Canal Filling sits #775 of 1000 among tracked device types with 703 MAUDE reports spanning 1997–2026. 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 →

Injury-coded reports run above the device-type norm

Resin, Root Canal Filling carries 93.5% INJURY-coded reports, 63.2pp 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 93.5% corpus 30.3% · above corpus mean (+63.2 pp)
  • MALF 5.8% corpus 64.8% · below corpus mean (-59.0 pp)

Lead product-problem code Insufficient Device Problem Information is 30% of coded problems · Top event location is 91% of location-tagged rows .

Resin, Root Canal Filling in the event-volume neighbourhood

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

reports

What this shows Resin, Root Canal Filling carries 703 MAUDE reports, ranked #775 of 1000.

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

Event Types

Injury 657 (93.5%)
Malfunction 41 (5.8%)
Other 5 (0.7%)

Patient Outcomes

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

Other 539 (45.0%)
R 485 (40.5%)
87 (7.3%)
Required Intervention 59 (4.9%)
Disability 10 (0.8%)
Hospitalization 8 (0.7%)
S 5 (0.4%)
O 3 (0.3%)
L 2 (0.2%)

Top Product Problems

Insufficient Device Problem Information 225
Device Operates Differently Than Expected 128
Adverse Event Without Identified Device or Use Problem 119
Material Erosion 44
Patient-Device Incompatibility 44
Loss of or Failure to Bond 35
Material Disintegration 32
Overfill 23
Material Integrity Problem 21
Failure To Adhere Or Bond 15
Lack of Effect 13
Appropriate Device Problem Term/Code Not Available 11
Improper or Incorrect Procedure or Method 9
Material Discolored 6
Other (for use when an appropriate device code cannot be identified) 6
Patient Device Interaction Problem 5
Replace 5
Unknown (for use when the device problem is not known) 5
Extrusion 4
Material Too Soft/Flexible 4

Yearly Trend

97
1997: 1
99
1999: 6
00
2000: 1
02
2002: 1
03
2003: 1
04
2004: 4
05
2005: 3
06
2006: 3
08
2008: 2
09
2009: 7
10
2010: 10
11
2011: 8
12
2012: 4
13
2013: 79
14
2014: 421
15
2015: 15
16
2016: 5
17
2017: 5
18
2018: 13
19
2019: 6
20
2020: 3
21
2021: 9
22
2022: 10
23
2023: 7
24
2024: 10
25
2025: 55
26
2026: 14

Reports rose to 55 in 2025, up from an average of 9 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Resin, Root Canal Filling

Event Locations

641 (91.2%)
I 48 (6.8%)
UNKNOWN 13 (1.8%)
NO INFORMATION 1 (0.1%)

Nationwide devices with a comparable report-volume footprint

Resin, Root Canal Filling 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 (703 here).

Coronary Covered Stent 702 Prosthesis 704 Lectins And Protectins 701 Oximeter, Tissue Saturation 706

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 Resin, Root Canal Filling 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 Resin, Root Canal Filling; 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.