Fastener, Fixation, Biodegradable, 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 §888.3030 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Fastener MID-BOOK · MAUDE
#159 of 1000 · 17,071 reports · 1996–2026
- BOOK 17,071 reports
- RANK #159 of 1000
- DEATH 0 death-typed
- INJ 4,099 injury-typed
- MALF 12,563 malfunction
- SPAN 1996–2026
- PEAK 2024: 2,301
- PHOTO Catheter, Urological
Nearest event-volume peer: Catheter, Urological (36 report gap)
Fastener, Fixation, Biodegradable, Soft Tissue sits #159 of 1000 among tracked device types with 17,071 MAUDE reports spanning 1996–2026. 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 73.6% MALFUNCTION-coded reports, 8.8pp 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 24.0% corpus 30.3% · below corpus mean (-6.3 pp)
- MALF 73.6% corpus 64.8% · above corpus mean (+8.8 pp)
Lead product-problem code Break is 60% of coded problems · Lead manufacturer DEPUY MITEK LLC US accounts for 45% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .
Fastener in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Console
Console, Heart-Lung Machine, Cardiopulmonary Bypass
17,288 reports
- System
System, Appendage Closure, Left Atrial
17,177 reports
- Fastener (this)
Fastener, Fixation, Biodegradable, Soft Tissue
17,071 reports
- Catheter
Catheter, Urological
17,035 reports
- Template
Template
16,915 reports
- Laparoscope
Laparoscope, Gynecologic (And Accessories)
16,889 reports
What this shows Fastener, Fixation, Biodegradable, Soft Tissue carries 17,071 MAUDE reports, ranked #159 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 (2,180) held close to the prior two-year average of 2,010.
Related Entities for Fastener, Fixation, Biodegradable, Soft Tissue
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Fastener 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 (17,071 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 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.