Gauge, Depth
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 §888.4300 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Gauge, Depth LIGHT-BOOK · MAUDE
#376 of 1000 · 3,439 reports · 1995–2026
- BOOK 3,439 reports
- RANK #376 of 1000
- DEATH 0 death-typed
- INJ 60 injury-typed
- MALF 3,377 malfunction
- SPAN 1995–2026
- PEAK 2025: 408
- PHOTO Active Implantable Bo…
Nearest event-volume peer: Active Implantable Bone Conduction Hearing System (2 report gap)
Gauge, Depth sits #376 of 1000 among tracked device types with 3,439 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 run above the device-type norm
Gauge, Depth carries 98.2% MALFUNCTION-coded reports, 33.4pp 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 1.7% corpus 30.3% · below corpus mean (-28.5 pp)
- MALF 98.2% corpus 64.8% · above corpus mean (+33.4 pp)
Lead product-problem code Break is 54% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 47% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .
Gauge, Depth in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Control
Control, Pump Speed, Cardiopulmonary Bypass
3,469 reports
- Catheters
Catheters, Suction, Tracheobronchial
3,457 reports
- Gauge, Depth (this)
Gauge, Depth
3,439 reports
- Active Implan…
Active Implantable Bone Conduction Hearing System
3,437 reports
- Adaptor
Adaptor, Hygiene
3,426 reports
- Driver
Driver, Wire, And Bone Drill, Manual
3,399 reports
What this shows Gauge, Depth carries 3,439 MAUDE reports, ranked #376 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 (408) held close to the prior two-year average of 374.
Related Entities for Gauge, Depth
Top Manufacturers
Event Locations
Compare SYNTHES GMBH vs WRIGHTS LANE SYNTHES USA PRODUCTS LLC →
Nationwide devices with a comparable report-volume footprint
Gauge, Depth 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 (3,439 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 Gauge, Depth 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 Gauge, Depth; 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.