Tissue Expander And Accessories
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 Tissue Expander And Accessories LIGHT-BOOK · MAUDE
#314 of 1000 · 5,148 reports · 1993–2026
- BOOK 5,148 reports
- RANK #314 of 1000
- DEATH 4 death-typed
- INJ 4,246 injury-typed
- MALF 793 malfunction
- SPAN 1993–2026
- PEAK 2020: 639
- PHOTO Prosthesis
Nearest event-volume peer: Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing (2 report gap)
Tissue Expander And Accessories sits #314 of 1000 among tracked device types with 5,148 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 → · Lead manufacturer → · Similar-volume device →
Injury-coded reports run above the device-type norm
Tissue Expander And Accessories carries 82.5% INJURY-coded reports, 52.2pp 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 (-1.4 pp)
- INJ 82.5% corpus 30.3% · above corpus mean (+52.2 pp)
- MALF 15.4% corpus 64.8% · below corpus mean (-49.4 pp)
Lead product-problem code Material Rupture is 35% of coded problems · Lead manufacturer MENTOR TEXAS accounts for 56% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .
Tissue Expander And Accessories in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Light
Light, Surgical, Ceiling Mounted
5,203 reports
- Prosthesis
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
5,172 reports
- Anesthesia Co…
Anesthesia Conduction Kit
5,152 reports
- Tissue Expand… (this)
Tissue Expander And Accessories
5,148 reports
- Prosthesis
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
5,146 reports
- Accessories
Accessories, Arthroscopic
5,126 reports
What this shows Tissue Expander And Accessories carries 5,148 MAUDE reports, ranked #314 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 in 2025 (500) held close to the prior two-year average of 481.
Related Entities for Tissue Expander And Accessories
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Tissue Expander And Accessories: 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 (5,148 here).
Similar death-typed counts
Nearest other device types by death-typed report count (4 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Tissue Expander And Accessories 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 Tissue Expander And Accessories; 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.