Bur, Surgical, General & Plastic Surgery
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 §878.4820 (General, Plastic Surgery panel).
FDA MAUDE casebook
openFDA event book Bur, Surgical, General & Plastic Surgery LIGHT-BOOK · MAUDE
#487 of 1000 · 2,110 reports · 1993–2026
- BOOK 2,110 reports
- RANK #487 of 1000
- DEATH 0 death-typed
- INJ 173 injury-typed
- MALF 1,912 malfunction
- SPAN 1993–2026
- PEAK 2013: 899
- PHOTO Agent
Nearest event-volume peer: Agent, Absorbable Hemostatic, Collagen Based (2 report gap)
Bur, Surgical, General & Plastic Surgery sits #487 of 1000 among tracked device types with 2,110 MAUDE reports spanning 1993–2026. 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
Bur, Surgical, General & Plastic Surgery carries 90.6% MALFUNCTION-coded reports, 25.8pp 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 8.2% corpus 30.3% · below corpus mean (-22.1 pp)
- MALF 90.6% corpus 64.8% · above corpus mean (+25.8 pp)
Lead product-problem code Break is 34% of coded problems · Lead manufacturer DEPUY SYNTHES POWER TOOLS accounts for 54% of manufacturer-tagged reports · Top event location is 76% of location-tagged rows .
Bur, Surgical, General & Plastic Surgery in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Pancreatic St…
Pancreatic Stent, Covered, Metallic, Removable
2,138 reports
- Collector
Collector, Urine, (And Accessories) For Indwelling Catheter
2,118 reports
- Bur (this)
Bur, Surgical, General & Plastic Surgery
2,110 reports
- Agent
Agent, Absorbable Hemostatic, Collagen Based
2,108 reports
- Hydrogel Spac…
Hydrogel Spacer
2,087 reports
- Catheter
Catheter, Percutaneous, Cutting/Scoring
2,083 reports
What this shows Bur, Surgical, General & Plastic Surgery carries 2,110 MAUDE reports, ranked #487 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 (72) held close to the prior two-year average of 110.
Related Entities for Bur, Surgical, General & Plastic Surgery
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Bur, Surgical, General & Plastic Surgery 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 (2,110 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 Bur, Surgical, General & Plastic Surgery 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 Bur, Surgical, General & Plastic Surgery; 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.