Orthosis, Limb Brace
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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §890.3475 (Physical Medicine panel).
FDA MAUDE casebook
openFDA event book Orthosis, Limb Brace LIGHT-BOOK · MAUDE
#927 of 1000 · 456 reports · 1995–2026
- BOOK 456 reports
- RANK #927 of 1000
- DEATH 2 death-typed
- INJ 197 injury-typed
- MALF 193 malfunction
- SPAN 1995–2026
- PEAK 2017: 93
- PHOTO Dispenser, Cement
Nearest event-volume peer: Dispenser, Cement (0 report gap)
Orthosis, Limb Brace sits #927 of 1000 among tracked device types with 456 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 sit below the device-type norm
Orthosis, Limb Brace carries 42.3% MALFUNCTION-coded reports, 22.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
- INJ 43.2% corpus 30.3% · above corpus mean (+12.9 pp)
- MALF 42.3% corpus 64.8% · below corpus mean (-22.5 pp)
Lead product-problem code Material Separation is 25% of coded problems · Lead manufacturer BECTON DICKINSON accounts for 100% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .
Orthosis, Limb Brace in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Patient Bed W…
Patient Bed With Canopy/Restraints
462 reports
- Cable
Cable, Electrode
459 reports
- Orthosis (this)
Orthosis, Limb Brace
456 reports
- Dispenser
Dispenser, Cement
456 reports
- Tray, Surgical
Tray, Surgical
452 reports
- Blood Groupin…
Blood Grouping Reagent
451 reports
What this shows Orthosis, Limb Brace carries 456 MAUDE reports, ranked #927 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 8 in 2025, up from an average of 3 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Orthosis, Limb Brace
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Orthosis, Limb Brace: 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 (456 here).
Similar death-typed counts
Nearest other device types by death-typed report count (2 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Orthosis, Limb Brace 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 Orthosis, Limb Brace; 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.