Fastener, Fixation, Nondegradable, Soft Tissue
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 §888.3040 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Fastener MID-BOOK · MAUDE
#120 of 1000 · 25,623 reports · 1995–2026
- BOOK 25,623 reports
- RANK #120 of 1000
- DEATH 5 death-typed
- INJ 6,124 injury-typed
- MALF 19,310 malfunction
- SPAN 1995–2026
- PEAK 2025: 3,875
- PHOTO Arthroscope
Nearest event-volume peer: Arthroscope (132 report gap)
Fastener, Fixation, Nondegradable, Soft Tissue sits #120 of 1000 among tracked device types with 25,623 MAUDE reports spanning 1995–2026. 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
Fastener carries 75.4% MALFUNCTION-coded reports, 10.5pp 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 23.9% corpus 30.3% · below corpus mean (-6.4 pp)
- MALF 75.4% corpus 64.8% · above corpus mean (+10.5 pp)
Lead product-problem code Break is 38% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 29% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .
Fastener in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Prosthesis
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
25,951 reports
- Fastener (this)
Fastener, Fixation, Nondegradable, Soft Tissue
25,623 reports
- Arthroscope
Arthroscope
25,491 reports
- Heart-Valve
Heart-Valve, Non-Allograft Tissue
25,471 reports
- Shunt
Shunt, Central Nervous System And Components
25,418 reports
- Mitral Valve…
Mitral Valve Repair Devices
25,400 reports
What this shows Fastener, Fixation, Nondegradable, Soft Tissue carries 25,623 MAUDE reports, ranked #120 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 (3,875) held close to the prior two-year average of 3,141.
Related Entities for Fastener, Fixation, Nondegradable, Soft Tissue
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Fastener: 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 (25,623 here).
Similar death-typed counts
Nearest other device types by death-typed report count (5 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Fastener 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 Fastener; 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.