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2026 data FDA MAUDE openFDA FDA Class II

Marker, Radiographic, Implantable

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 §878.4300 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Marker, Radiographic, Implantable LIGHT-BOOK · MAUDE

#517 of 1000 · 1,851 reports · 2002–2026

  • BOOK 1,851 reports
  • RANK #517 of 1000
  • DEATH 1 death-typed
  • INJ 1,169 injury-typed
  • MALF 651 malfunction
  • SPAN 2002–2026
  • PEAK 2025: 417
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Intracardiac Mapping, High-Density Array (12 report gap)

Marker, Radiographic, Implantable sits #517 of 1000 among tracked device types with 1,851 MAUDE reports spanning 2002–2026. 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 → · Lead manufacturer → · Similar-volume device →

Injury-coded reports run above the device-type norm

Marker, Radiographic, Implantable carries 63.2% INJURY-coded reports, 32.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 63.2% corpus 30.3% · above corpus mean (+32.9 pp)
  • MALF 35.2% corpus 64.8% · below corpus mean (-29.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 47% of coded problems · Lead manufacturer HOLOGIC, INC. accounts for 40% of manufacturer-tagged reports · Top event location is 70% of location-tagged rows .

Marker, Radiographic, Implantable in the event-volume neighbourhood

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

reports

What this shows Marker, Radiographic, Implantable carries 1,851 MAUDE reports, ranked #517 of 1000.

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

Event Types

Injury 1,169 (63.2%)
Malfunction 651 (35.2%)
Other 22 (1.2%)
8 (0.4%)
Death 1 (0.1%)

Patient Outcomes

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

Other 844 (39.5%)
671 (31.4%)
Required Intervention 180 (8.4%)
O 118 (5.5%)
Hospitalization 101 (4.7%)
H 80 (3.7%)
R 76 (3.6%)
Disability 26 (1.2%)
S 20 (0.9%)
Life Threatening 13 (0.6%)
L 4 (0.2%)
Death 2 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 766
Break 92
Device Damaged by Another Device 78
Positioning Failure 74
Migration 66
Patient-Device Incompatibility 61
Migration or Expulsion of Device 60
Use of Device Problem 53
Appropriate Device Problem Term/Code Not Available 51
Detachment of Device or Device Component 43
Material Fragmentation 42
Bent 37
Insufficient Device Problem Information 36
Difficult to Remove 35
Fracture 28
Detachment Of Device Component 25
Activation, Positioning or Separation Problem 23
Patient Device Interaction Problem 21
Device Contamination with Chemical or Other Material 18
Component Missing 16

Yearly Trend

02
2002: 1
03
2003: 2
04
2004: 12
05
2005: 7
06
2006: 2
07
2007: 5
08
2008: 5
09
2009: 30
10
2010: 12
11
2011: 18
12
2012: 54
13
2013: 60
14
2014: 38
15
2015: 120
16
2016: 56
17
2017: 69
18
2018: 66
19
2019: 58
20
2020: 45
21
2021: 82
22
2022: 100
23
2023: 142
24
2024: 247
25
2025: 417
26
2026: 203

Reports rose to 417 in 2025, up from an average of 195 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Marker, Radiographic, Implantable

Top Manufacturers

HOLOGIC, INC. 462
HOLOGIC, INC 349
BARD PERIPHERAL VASCULAR, INC. 272
COOK ENDOSCOPY 40
MERIT MEDICAL SYSTEMS, INC. 36

Event Locations

1,287 (69.5%)
I 305 (16.5%)
HOSPITAL 163 (8.8%)
NO INFORMATION 37 (2.0%)
OUTPATIENT DIAGNOSTIC FACILITY 33 (1.8%)
OTHER 14 (0.8%)
OUTPATIENT TREATMENT FACILITY 7 (0.4%)
NOT APPLICABLE 5 (0.3%)

Compare HOLOGIC, INC. vs HOLOGIC, INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Marker, Radiographic, Implantable: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,851 here).

Catheter 1,863 Disinfectant, Medical Devices 1,864 Set, Blood Transfusion 1,836 Tubing, Pump, Cardiopulmonary Bypass 1,866

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Marker, Radiographic, Implantable 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 Marker, Radiographic, Implantable; 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.