What are FDA adverse event reports for Marker, Radiographic, Implantable?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Marker, Radiographic, Implantable, there are 1,671 total reports including 1 death reports and 1,016 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Marker, Radiographic, Implantable?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Marker, Radiographic, Implantable

Name: Marker, Radiographic, Implantable - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

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

#524 of 1000 · 1,671 reports · 2002–2026

BOOK 1,671 reports
RANK #524 of 1000
DEATH 1 death-typed
INJ 1,016 injury-typed
MALF 624 malfunction
SPAN 2002–2026
PEAK 2025: 417
PHOTO Ear

Nearest event-volume peer: Ear, Nose, And Throat Stereotaxic Instrument (1 report gap)

Marker, Radiographic, Implantable sits #524 of 1000 among tracked device types with 1,671 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

DEATH 0.1% corpus 1.5% · below corpus mean (-1.5 pp)
INJ 60.8% corpus 30.4% · above corpus mean (+30.4 pp)
MALF 37.3% corpus 64.5% · below corpus mean (-27.2 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 53% of coded problems · Lead manufacturer HOLOGIC, INC accounts for 36% of manufacturer-tagged reports · Top event location is 67% of location-tagged rows .

Ear

1,672
Marker (this)

1,671
Apparatus

1,667
Sleeve

1,664
Adhesive

1,663
Monitor

1,663

What this shows Marker, Radiographic, Implantable carries 1,671 MAUDE reports, ranked #524 of 1000.

Event Types

Injury 1,016 (60.8%)

Malfunction 624 (37.3%)

Other 22 (1.3%)

8 (0.5%)

Death 1 (0.1%)

Patient Outcomes

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

Other 707 (36.1%)

651 (33.2%)

Required Intervention 169 (8.6%)

O 116 (5.9%)

Hospitalization 100 (5.1%)

H 79 (4.0%)

R 75 (3.8%)

Disability 26 (1.3%)

S 19 (1.0%)

Life Threatening 13 (0.7%)

L 4 (0.2%)

Death 2 (0.1%)

Yearly Trend

2002: 1

2003: 2

2004: 12

2005: 7

2006: 2

2007: 5

2008: 5

2009: 30

2010: 12

2011: 18

2012: 54

2013: 60

2014: 38

2015: 120

2016: 56

2017: 69

2018: 66

2019: 58

2020: 45

2021: 82

2022: 100

2023: 142

2024: 247

2025: 417

2026: 23

Top Manufacturers

HOLOGIC, INC 365

HOLOGIC, INC. 305

BARD PERIPHERAL VASCULAR, INC. 262

COOK ENDOSCOPY 40

MERIT MEDICAL SYSTEMS, INC. 31

Event Locations

1,112 (66.5%)

I 305 (18.3%)

HOSPITAL 160 (9.6%)

NO INFORMATION 37 (2.2%)

OUTPATIENT DIAGNOSTIC FACILITY 32 (1.9%)

OTHER 14 (0.8%)

OUTPATIENT TREATMENT FACILITY 6 (0.4%)

NOT APPLICABLE 5 (0.3%)

Compare HOLOGIC, INC vs HOLOGIC, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Marker, Radiographic, Implantable, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,671 here).

Ear, Nose, And Throat Stereotaxic Instrument 1,672 Apparatus 1,667 Sleeve, Limb, Compressible 1,664 Adhesive 1,663

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.

Marker, Radiographic, Implantable

Event-type mix vs corpus