2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Gauge, Depth LIGHT-BOOK · MAUDE

#373 of 1000 · 3,274 reports · 1995–2026

  • BOOK 3,274 reports
  • RANK #373 of 1000
  • DEATH 0 death-typed
  • INJ 58 injury-typed
  • MALF 3,214 malfunction
  • SPAN 1995–2026
  • PEAK 2025: 408
  • PHOTO Injector And Syringe

Nearest event-volume peer: Injector And Syringe, Angiographic (9 report gap)

Gauge, Depth sits #373 of 1000 among tracked device types with 3,274 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 1.8% corpus 30.4% · below corpus mean (-28.7 pp)
  • MALF 98.2% corpus 64.5% · above corpus mean (+33.7 pp)

Lead product-problem code Break is 54% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 45% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .

Gauge, Depth in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Gauge, Depth carries 3,274 MAUDE reports, ranked #373 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 3,214 (98.2%)
Injury 58 (1.8%)
Other 2 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

3,145 (97.3%)
Required Intervention 49 (1.5%)
Other 26 (0.8%)
Hospitalization 7 (0.2%)
R 3 (0.1%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Break 1,661
Material Deformation 614
Mechanical Jam 173
Device-Device Incompatibility 101
Incorrect Measurement 93
Fracture 50
Use of Device Problem 44
Material Fragmentation 41
Material Twisted/Bent 41
Component Missing 35
Detachment of Device or Device Component 35
Material Integrity Problem 27
Mechanical Problem 26
Device Operates Differently Than Expected 25
Naturally Worn 25
Illegible Information 23
Material Discolored 19
Bent 16
Device Slipped 15
Appropriate Term/Code Not Available 13

Yearly Trend

95
1995: 1
96
1996: 1
97
1997: 5
98
1998: 1
00
2000: 2
02
2002: 3
06
2006: 1
07
2007: 1
09
2009: 1
10
2010: 5
11
2011: 2
12
2012: 6
13
2013: 142
14
2014: 106
15
2015: 139
16
2016: 178
17
2017: 82
18
2018: 104
19
2019: 196
20
2020: 354
21
2021: 403
22
2022: 316
23
2023: 376
24
2024: 371
25
2025: 408
26
2026: 70

Related Entities for Gauge, Depth

Event Locations

1,971 (60.2%)
I 1,289 (39.4%)
HOSPITAL 10 (0.3%)
NO INFORMATION 2 (0.1%)
OTHER 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare SYNTHES GMBH vs WRIGHTS LANE SYNTHES USA PRODUCTS LLC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Gauge, Depth, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

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.