Digital Breast Tomosynthesis
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 MAUDE casebook
openFDA event book Digital Breast Tomosynthesis LIGHT-BOOK · MAUDE
#673 of 1000 · 975 reports · 2014–2026
- BOOK 975 reports
- RANK #673 of 1000
- DEATH 12 death-typed
- INJ 44 injury-typed
- MALF 918 malfunction
- SPAN 2014–2026
- PEAK 2017: 166
- PHOTO Bronchoscope Accessory
Nearest event-volume peer: Bronchoscope Accessory (2 report gap)
Digital Breast Tomosynthesis sits #673 of 1000 among tracked device types with 975 MAUDE reports spanning 2014–2026. 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 →
Malfunction reports run above the device-type norm
Digital Breast Tomosynthesis carries 94.2% MALFUNCTION-coded reports, 29.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.2% corpus 1.5% · near corpus mean (-0.3 pp)
- INJ 4.5% corpus 30.3% · below corpus mean (-25.8 pp)
- MALF 94.2% corpus 64.8% · above corpus mean (+29.3 pp)
Lead product-problem code Unintended System Motion is 55% of coded problems · Lead manufacturer HOLOGIC, INC accounts for 63% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .
Digital Breast Tomosynthesis in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Hepatitis A T…
Hepatitis A Test (Antibody And Igm Antibody)
982 reports
- Single-Use Re…
Single-Use Reprocessed Ultrasonic Surgical Instruments
980 reports
- Container
Container, Sharps
979 reports
- Bronchoscope…
Bronchoscope Accessory
977 reports
- Digital Breas… (this)
Digital Breast Tomosynthesis
975 reports
- Blade, Scalpel
Blade, Scalpel
970 reports
What this shows Digital Breast Tomosynthesis carries 975 MAUDE reports, ranked #673 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 142 in 2025, up from an average of 95 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Digital Breast Tomosynthesis
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Digital Breast Tomosynthesis: 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 (975 here).
Similar death-typed counts
Nearest other device types by death-typed report count (12 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Digital Breast Tomosynthesis 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 Digital Breast Tomosynthesis; 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.