2025 data FDA MAUDE openFDA FDA Class III

Scaffold, Dissection Repair

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 Scaffold, Dissection Repair LIGHT-BOOK · MAUDE

#909 of 1000 · 478 reports · 2019–2025

  • BOOK 478 reports
  • RANK #909 of 1000
  • DEATH 0 death-typed
  • INJ 35 injury-typed
  • MALF 443 malfunction
  • SPAN 2019–2025
  • PEAK 2024: 464
  • PHOTO Enzyme Immunoassay

Nearest event-volume peer: Enzyme Immunoassay, Digoxin (0 report gap)

Scaffold, Dissection Repair sits #909 of 1000 among tracked device types with 478 MAUDE reports spanning 2019–2025. 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 →

Malfunction reports run above the device-type norm

Scaffold, Dissection Repair carries 92.7% MALFUNCTION-coded reports, 27.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 7.3% corpus 30.3% · below corpus mean (-23.0 pp)
  • MALF 92.7% corpus 64.8% · above corpus mean (+27.9 pp)

Lead product-problem code Unintended Movement is 33% of coded problems · Top event location is 99% of location-tagged rows .

Scaffold, Dissection Repair in the event-volume neighbourhood

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

reports

What this shows Scaffold, Dissection Repair carries 478 MAUDE reports, ranked #909 of 1000.

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

Event Types

Malfunction 443 (92.7%)
Injury 35 (7.3%)

Patient Outcomes

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

467 (97.7%)
Required Intervention 11 (2.3%)

Top Product Problems

Unintended Movement 160
Ejection Problem 156
Positioning Failure 107
Failure to Unfold or Unwrap 14
Unintended Ejection 12
Entrapment of Device 6
Malposition of Device 6
Improper or Incorrect Procedure or Method 4
Unintended Collision 4
Device Damaged by Another Device 3
Adverse Event Without Identified Device or Use Problem 2
Device Dislodged or Dislocated 2
Material Separation 2
Migration 2
Human-Device Interface Problem 1
Inadequacy of Device Shape and/or Size 1
Insufficient Device Problem Information 1
Off-Label Use 1
Positioning Problem 1
Retraction Problem 1

Yearly Trend

19
2019: 1
20
2020: 3
21
2021: 6
22
2022: 2
23
2023: 1
24
2024: 464
25
2025: 1

Reports rose to 464 in 2024, up from an average of 2 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Scaffold, Dissection Repair

Event Locations

471 (98.5%)
I 7 (1.5%)

Nationwide devices with a comparable report-volume footprint

Scaffold, Dissection Repair carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (478 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Scaffold, Dissection Repair 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 Scaffold, Dissection Repair; 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.