Plate, Fixation, Bone
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 Plate, Fixation, Bone MID-BOOK · MAUDE
#87 of 1000 · 38,818 reports · 1992–2026
- BOOK 38,818 reports
- RANK #87 of 1000
- DEATH 73 death-typed
- INJ 29,405 injury-typed
- MALF 8,868 malfunction
- SPAN 1992–2026
- PEAK 2019: 3,358
- PHOTO Mesh
Nearest event-volume peer: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (172 report gap)
Plate, Fixation, Bone sits #87 of 1000 among tracked device types with 38,818 MAUDE reports spanning 1992–2026. 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
Plate, Fixation, Bone carries 75.8% INJURY-coded reports, 45.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
- INJ 75.8% corpus 30.3% · above corpus mean (+45.5 pp)
- MALF 22.8% corpus 64.8% · below corpus mean (-42.0 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 34% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 20% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .
Plate, Fixation, Bone in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Needle
Needle, Hypodermic, Single Lumen
39,692 reports
- Plate (this)
Plate, Fixation, Bone
38,818 reports
- Mesh
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
38,646 reports
- Device
Device, Impotence, Mechanical/Hydraulic
38,353 reports
- Filter
Filter, Intravascular, Cardiovascular
38,320 reports
- Insulin Pump…
Insulin Pump Secondary Display
38,005 reports
What this shows Plate, Fixation, Bone carries 38,818 MAUDE reports, ranked #87 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 (2,334) held close to the prior two-year average of 1,949.
Related Entities for Plate, Fixation, Bone
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Plate, Fixation, Bone: 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 (38,818 here).
Similar death-typed counts
Nearest other device types by death-typed report count (73 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Plate, Fixation, Bone 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 Plate, Fixation, Bone; 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.