PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Cement, Dental

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 §872.3275 (Dental panel).

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FDA MAUDE casebook

openFDA event book Cement, Dental LIGHT-BOOK · MAUDE

#548 of 1000 · 1,630 reports · 1993–2026

  • BOOK 1,630 reports
  • RANK #548 of 1000
  • DEATH 0 death-typed
  • INJ 1,440 injury-typed
  • MALF 140 malfunction
  • SPAN 1993–2026
  • PEAK 2013: 385
  • PHOTO Endoscopic Guidewire

Nearest event-volume peer: Endoscopic Guidewire, Gastroenterology-Urology (5 report gap)

Cement, Dental sits #548 of 1000 among tracked device types with 1,630 MAUDE reports spanning 1993–2026. 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

Cement, Dental carries 88.3% INJURY-coded reports, 58.1pp 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 88.3% corpus 30.3% · above corpus mean (+58.1 pp)
  • MALF 8.6% corpus 64.8% · below corpus mean (-56.2 pp)

Lead product-problem code Loss of or Failure to Bond is 32% of coded problems · Top event location is 91% of location-tagged rows .

Cement, Dental in the event-volume neighbourhood

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

reports

What this shows Cement, Dental carries 1,630 MAUDE reports, ranked #548 of 1000.

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

Event Types

Injury 1,440 (88.3%)
Malfunction 140 (8.6%)
Other 42 (2.6%)
8 (0.5%)

Patient Outcomes

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

Other 1,302 (50.1%)
R 951 (36.6%)
Required Intervention 255 (9.8%)
44 (1.7%)
Hospitalization 17 (0.7%)
O 8 (0.3%)
Disability 7 (0.3%)
S 5 (0.2%)
Life Threatening 5 (0.2%)
L 3 (0.1%)
H 1 (0.0%)

Top Product Problems

Loss of or Failure to Bond 562
Insufficient Device Problem Information 181
Device Operates Differently Than Expected 130
Nonstandard Device 115
Material Discolored 91
Detachment Of Device Component 90
Failure To Adhere Or Bond 89
Appropriate Device Problem Term/Code Not Available 88
Patient-Device Incompatibility 69
Component Falling 65
Crack 46
Adverse Event Without Identified Device or Use Problem 42
Unknown (for use when the device problem is not known) 40
Reaction 27
Material Integrity Problem 21
Difficult to Remove 20
Material Separation 18
Component Missing 17
Other (for use when an appropriate device code cannot be identified) 15
Device Issue 13

Yearly Trend

93
1993: 2
94
1994: 2
96
1996: 2
97
1997: 5
98
1998: 5
99
1999: 10
00
2000: 13
01
2001: 8
02
2002: 6
03
2003: 12
04
2004: 32
05
2005: 11
06
2006: 7
07
2007: 33
08
2008: 50
09
2009: 90
10
2010: 106
11
2011: 224
12
2012: 249
13
2013: 385
14
2014: 207
15
2015: 85
16
2016: 16
17
2017: 13
18
2018: 4
19
2019: 12
20
2020: 5
21
2021: 8
22
2022: 3
23
2023: 6
24
2024: 5
25
2025: 9
26
2026: 5

Reports rose to 9 in 2025, up from an average of 6 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Cement, Dental

Event Locations

1,476 (90.6%)
I 112 (6.9%)
OTHER 16 (1.0%)
NO INFORMATION 11 (0.7%)
HOSPITAL 4 (0.2%)
INVALID DATA 4 (0.2%)
HOME 2 (0.1%)
OUTPATIENT TREATMENT FACILITY 2 (0.1%)
UNKNOWN 2 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)

Nationwide devices with a comparable report-volume footprint

Cement, Dental 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 (1,630 here).

Endoscopic Guidewire 1,635 Retractor 1,646 Microfilter, Blood Transfusion 1,648 Set, Tubing And Support, Ventilator 1,654

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 Cement, Dental 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 Cement, Dental; 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.