2026 data FDA MAUDE openFDA FDA Class I

Clamp

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 §878.4800 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Clamp LIGHT-BOOK · MAUDE

#615 of 1000 · 1,235 reports · 1993–2026

  • BOOK 1,235 reports
  • RANK #615 of 1000
  • DEATH 0 death-typed
  • INJ 36 injury-typed
  • MALF 1,192 malfunction
  • SPAN 1993–2026
  • PEAK 2024: 135
  • PHOTO Lamp, Surgical

Nearest event-volume peer: Lamp, Surgical (3 report gap)

Clamp sits #615 of 1000 among tracked device types with 1,235 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

Clamp carries 96.5% MALFUNCTION-coded reports, 31.7pp 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 2.9% corpus 30.3% · below corpus mean (-27.4 pp)
  • MALF 96.5% corpus 64.8% · above corpus mean (+31.7 pp)

Lead product-problem code Device-Device Incompatibility is 27% of coded problems · Lead manufacturer DEPUY IRELAND - 9616671 accounts for 34% of manufacturer-tagged reports · Top event location I is 50% of location-tagged rows .

Clamp in the event-volume neighbourhood

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

reports

What this shows Clamp carries 1,235 MAUDE reports, ranked #615 of 1000.

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

Event Types

Malfunction 1,192 (96.5%)
Injury 36 (2.9%)
Other 5 (0.4%)
2 (0.2%)

Patient Outcomes

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

1,149 (92.7%)
Other 46 (3.7%)
Required Intervention 28 (2.3%)
R 6 (0.5%)
Life Threatening 4 (0.3%)
Disability 3 (0.2%)
Hospitalization 3 (0.2%)
L 1 (0.1%)

Top Product Problems

Device-Device Incompatibility 358
Break 322
Mechanical Jam 125
Appropriate Device Problem Term/Code Not Available 106
Structural Problem 85
Naturally Worn 51
Mechanical Problem 34
Fracture 33
Component Missing 29
Detachment of Device or Device Component 23
Crack 22
Physical Resistance/Sticking 22
Material Deformation 20
Difficult to Open or Close 19
Device Slipped 18
Material Twisted/Bent 18
Unintended Movement 18
Fitting Problem 11
Connection Problem 10
Material Integrity Problem 10

Yearly Trend

93
1993: 2
97
1997: 1
98
1998: 1
99
1999: 1
02
2002: 2
03
2003: 8
04
2004: 3
06
2006: 4
07
2007: 6
08
2008: 4
09
2009: 26
10
2010: 2
11
2011: 4
13
2013: 6
14
2014: 4
15
2015: 6
16
2016: 76
17
2017: 131
18
2018: 112
19
2019: 125
20
2020: 114
21
2021: 75
22
2022: 88
23
2023: 99
24
2024: 135
25
2025: 124
26
2026: 76

Reports in 2025 (124) held close to the prior two-year average of 117.

Related Entities for Clamp

Event Locations

I 612 (49.6%)
596 (48.3%)
HOSPITAL 18 (1.5%)
NO INFORMATION 5 (0.4%)
HOME 3 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare DEPUY IRELAND - 9616671 vs DEPUY ORTHOPAEDICS INC US →

Nationwide devices with a comparable report-volume footprint

Clamp 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 (1,235 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Clamp 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 Clamp; 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.