Driver, Prosthesis
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 §888.4540 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Driver, Prosthesis LIGHT-BOOK · MAUDE
#220 of 1000 · 9,682 reports · 1996–2026
- BOOK 9,682 reports
- RANK #220 of 1000
- DEATH 1 death-typed
- INJ 234 injury-typed
- MALF 9,445 malfunction
- SPAN 1996–2026
- PEAK 2023: 1,280
- PHOTO Ring, Annuloplasty
Nearest event-volume peer: Ring, Annuloplasty (9 report gap)
Driver, Prosthesis sits #220 of 1000 among tracked device types with 9,682 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
Driver, Prosthesis carries 97.6% MALFUNCTION-coded reports, 32.7pp 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 2.4% corpus 30.3% · below corpus mean (-27.9 pp)
- MALF 97.6% corpus 64.8% · above corpus mean (+32.7 pp)
Lead product-problem code Break is 46% of coded problems · Lead manufacturer DEPUY SPINE INC accounts for 32% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .
Driver, Prosthesis in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Appliance
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
9,903 reports
- Driver (this)
Driver, Prosthesis
9,682 reports
- Ring
Ring, Annuloplasty
9,673 reports
- Prosthesis
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
9,644 reports
- Motor
Motor, Drill, Pneumatic
9,613 reports
- Keratome
Keratome, Ac-Powered
9,578 reports
What this shows Driver, Prosthesis carries 9,682 MAUDE reports, ranked #220 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 (1,226) held close to the prior two-year average of 1,246.
Related Entities for Driver, Prosthesis
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Driver, Prosthesis: 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 (9,682 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Driver, Prosthesis 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 Driver, Prosthesis; 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.