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2026 data FDA MAUDE openFDA

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

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.

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FDA MAUDE casebook

openFDA event book Suture LIGHT-BOOK · MAUDE

#684 of 1000 · 874 reports · 1993–2026

  • BOOK 874 reports
  • RANK #684 of 1000
  • DEATH 7 death-typed
  • INJ 206 injury-typed
  • MALF 654 malfunction
  • SPAN 1993–2026
  • PEAK 2024: 176
  • PHOTO Graft

Nearest event-volume peer: Graft, Vascular, Synthetic/Biologic Composite (4 report gap)

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile sits #684 of 1000 among tracked device types with 874 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 →

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 0.8% corpus 1.5% · below corpus mean (-0.7 pp)
  • INJ 23.6% corpus 30.4% · below corpus mean (-6.9 pp)
  • MALF 74.8% corpus 64.5% · above corpus mean (+10.3 pp)

Lead product-problem code Break is 35% of coded problems · Lead manufacturer ETHICON INC. accounts for 69% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .

Suture in the event-volume neighbourhood

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

reports

What this shows Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile carries 874 MAUDE reports, ranked #684 of 1000.

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

Event Types

Malfunction 654 (74.8%)
Injury 206 (23.6%)
Death 7 (0.8%)
4 (0.5%)
Other 3 (0.3%)

Patient Outcomes

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

635 (68.8%)
Required Intervention 152 (16.5%)
Other 55 (6.0%)
R 25 (2.7%)
Hospitalization 21 (2.3%)
O 9 (1.0%)
L 8 (0.9%)
Death 7 (0.8%)
H 6 (0.7%)
S 2 (0.2%)
Life Threatening 2 (0.2%)
Disability 1 (0.1%)

Top Product Problems

Break 259
Material Separation 258
Detachment of Device or Device Component 95
Adverse Event Without Identified Device or Use Problem 38
Appropriate Term/Code Not Available 17
Material Twisted/Bent 15
Device Contaminated During Manufacture or Shipping 9
Dull, Blunt 9
Defective Component 7
Bent 5
Delivered as Unsterile Product 5
Product Quality Problem 4
Unraveled Material 4
Detachment Of Device Component 3
Incorrect Device Or Component Shipped 3
Manufacturing, Packaging or Shipping Problem 2
Material Frayed 2
Material Integrity Problem 2
Packaging Problem 2
Unclear Information 2

Yearly Trend

93
1993: 2
94
1994: 1
95
1995: 1
96
1996: 7
97
1997: 14
98
1998: 4
99
1999: 3
00
2000: 6
01
2001: 3
02
2002: 9
03
2003: 10
04
2004: 2
05
2005: 4
06
2006: 4
07
2007: 7
08
2008: 4
09
2009: 7
10
2010: 13
11
2011: 19
12
2012: 10
13
2013: 16
14
2014: 18
15
2015: 17
16
2016: 23
17
2017: 11
18
2018: 53
19
2019: 76
20
2020: 52
21
2021: 39
22
2022: 70
23
2023: 100
24
2024: 176
25
2025: 86
26
2026: 7

Related Entities for Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

Top Manufacturers

ETHICON INC. 537
DAVIS & GECK CARIBE LTD 153
ETHICON, INC. 59
UNITED STATES SURGICAL CORP. 12
ETHICON, INC 8
TELEFLEX MEDICAL 6

Event Locations

523 (59.8%)
I 228 (26.1%)
HOSPITAL 59 (6.8%)
OTHER 40 (4.6%)
NO INFORMATION 9 (1.0%)
INVALID DATA 8 (0.9%)
UNKNOWN 5 (0.6%)
HOME 2 (0.2%)

Compare ETHICON INC. vs DAVIS & GECK CARIBE LTD →

Nationwide devices with similar MAUDE profiles

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

Similar report volume

Nearest other device types by FDA MAUDE report count (874 here).

Graft 870 Condylar Plate Fixation Implant 868 Catheter Care Tray 881 Culture Media 866

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Device, Warming. Blood And Plasma 7 Dressing, Wound, Occlusive 7 Image-Intensified Fluoroscopic X-Ray System 7 Instrument 7

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Suture 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 Suture; 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.