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2026 data FDA MAUDE openFDA FDA Class II

Material, Impression

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 §872.3660 (Dental panel).

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FDA MAUDE casebook

openFDA event book Material, Impression LIGHT-BOOK · MAUDE

#996 of 1000 · 369 reports · 1996–2026

  • BOOK 369 reports
  • RANK #996 of 1000
  • DEATH 0 death-typed
  • INJ 311 injury-typed
  • MALF 13 malfunction
  • SPAN 1996–2026
  • PEAK 2014: 35
  • PHOTO Light

Nearest event-volume peer: Light, Surgical, Accessories (0 report gap)

Material, Impression sits #996 of 1000 among tracked device types with 369 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 sit below the device-type norm

Material, Impression carries 3.5% MALFUNCTION-coded reports, 61.3pp below 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 84.3% corpus 30.3% · above corpus mean (+54.0 pp)
  • MALF 3.5% corpus 64.8% · below corpus mean (-61.3 pp)

Lead product-problem code Patient-Device Incompatibility is 34% of coded problems · Top event location is 66% of location-tagged rows .

Material, Impression in the event-volume neighbourhood

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

reports

What this shows Material, Impression carries 369 MAUDE reports, ranked #996 of 1000.

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

Event Types

Injury 311 (84.3%)
Other 31 (8.4%)
14 (3.8%)
Malfunction 13 (3.5%)

Patient Outcomes

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

Other 198 (46.6%)
Required Intervention 75 (17.6%)
48 (11.3%)
Hospitalization 42 (9.9%)
R 37 (8.7%)
O 12 (2.8%)
L 7 (1.6%)
Disability 2 (0.5%)
Life Threatening 2 (0.5%)
S 1 (0.2%)
Congenital Anomaly 1 (0.2%)

Top Product Problems

Patient-Device Incompatibility 130
Adverse Event Without Identified Device or Use Problem 61
Unknown (for use when the device problem is not known) 48
Insufficient Device Problem Information 41
Fitting Problem 23
Reaction 15
Improper or Incorrect Procedure or Method 11
Difficult to Remove 9
Use of Device Problem 8
Device Operates Differently Than Expected 7
Appropriate Device Problem Term/Code Not Available 6
Device, removal of (non-implant) 4
Material Distortion 3
Off-Label Use 3
Device Appears to Trigger Rejection 2
Device Handling Problem 2
Entrapment of Device 2
Human-Device Interface Problem 2
Material Integrity Problem 2
Material Separation 2

Yearly Trend

96
1996: 2
97
1997: 2
98
1998: 3
99
1999: 5
00
2000: 3
01
2001: 2
02
2002: 3
03
2003: 22
04
2004: 10
05
2005: 9
06
2006: 10
07
2007: 9
08
2008: 17
09
2009: 7
10
2010: 16
11
2011: 15
12
2012: 14
13
2013: 32
14
2014: 35
15
2015: 18
16
2016: 15
17
2017: 17
18
2018: 14
19
2019: 24
20
2020: 8
21
2021: 6
22
2022: 9
23
2023: 13
24
2024: 3
25
2025: 24
26
2026: 2

Reports rose to 24 in 2025, up from an average of 8 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Material, Impression

Event Locations

242 (65.6%)
I 75 (20.3%)
OTHER 20 (5.4%)
UNKNOWN 16 (4.3%)
OUTPATIENT TREATMENT FACILITY 5 (1.4%)
HOME 4 (1.1%)
NO INFORMATION 4 (1.1%)
HOSPITAL 2 (0.5%)
NOT APPLICABLE 1 (0.3%)

Nationwide devices with a comparable report-volume footprint

Material, Impression 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 (369 here).

Light, Surgical, Accessories 369 Antigens, All Groups, Streptococcus Spp. 370 Photometric Method, Magnesium 370 Balloon Aortic Valvuloplasty 367

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 Material, Impression 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 Material, Impression; 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.