Implantable Transprostatic Tissue Retractor System
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 §876.5530 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Implantable Transprostatic Tissue Retractor… LIGHT-BOOK · MAUDE
#915 of 1000 · 471 reports · 2013–2026
- BOOK 471 reports
- RANK #915 of 1000
- DEATH 12 death-typed
- INJ 231 injury-typed
- MALF 228 malfunction
- SPAN 2013–2026
- PEAK 2025: 69
- PHOTO Mask, Oxygen
Nearest event-volume peer: Mask, Oxygen (1 report gap)
Implantable Transprostatic Tissue Retractor System sits #915 of 1000 among tracked device types with 471 MAUDE reports spanning 2013–2026. 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 →
Injury-coded reports run above the device-type norm
Implantable Transprostatic Tissue Retractor… carries 49.0% INJURY-coded reports, 18.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 2.5% corpus 1.5% · above corpus mean (+1.0 pp)
- INJ 49.0% corpus 30.3% · above corpus mean (+18.8 pp)
- MALF 48.4% corpus 64.8% · below corpus mean (-16.4 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 50% of coded problems · Top event location is 59% of location-tagged rows .
Implantable Transprostatic Tissue Retractor… in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Heart-Valve
Heart-Valve, Allograft
474 reports
- Microscope
Microscope, Surgical
473 reports
- System
System, Identification, Hepatitis B Antigen
472 reports
- Implantable T… (this)
Implantable Transprostatic Tissue Retractor System
471 reports
- Mask, Oxygen
Mask, Oxygen
470 reports
- Clip
Clip, Hemostatic
468 reports
What this shows Implantable Transprostatic Tissue Retractor System carries 471 MAUDE reports, ranked #915 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 69 in 2025, up from an average of 45 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Implantable Transprostatic Tissue Retractor System
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Implantable Transprostatic Tissue Retractor…: 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 (471 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 Implantable Transprostatic Tissue Retractor… 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 Implantable Transprostatic Tissue Retractor…; 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.