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2026 data FDA MAUDE openFDA

Suture, Nonabsorbable, Silk

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, Nonabsorbable, Silk LIGHT-BOOK · MAUDE

#356 of 1000 · 3,765 reports · 1992–2026

  • BOOK 3,765 reports
  • RANK #356 of 1000
  • DEATH 8 death-typed
  • INJ 750 injury-typed
  • MALF 2,998 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 488
  • PHOTO Visual

Nearest event-volume peer: Visual, Pregnancy Hcg, Prescription Use (28 report gap)

Suture, Nonabsorbable, Silk sits #356 of 1000 among tracked device types with 3,765 MAUDE reports spanning 1992–2026. 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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 19.9% corpus 30.4% · below corpus mean (-10.5 pp)
  • MALF 79.6% corpus 64.5% · above corpus mean (+15.1 pp)

Lead product-problem code Break is 55% of coded problems · Lead manufacturer ETHICON INC. accounts for 87% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Suture, Nonabsorbable, Silk in the event-volume neighbourhood

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

reports

What this shows Suture, Nonabsorbable, Silk carries 3,765 MAUDE reports, ranked #356 of 1000.

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

Event Types

Malfunction 2,998 (79.6%)
Injury 750 (19.9%)
Death 8 (0.2%)
Other 5 (0.1%)
4 (0.1%)

Patient Outcomes

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

2,927 (77.5%)
Required Intervention 619 (16.4%)
Other 183 (4.8%)
R 16 (0.4%)
Hospitalization 13 (0.3%)
O 9 (0.2%)
Death 8 (0.2%)
S 2 (0.1%)
Disability 2 (0.1%)

Top Product Problems

Break 1,934
Adverse Event Without Identified Device or Use Problem 535
Material Separation 382
Detachment of Device or Device Component 160
Material Split, Cut or Torn 96
Device Contaminated During Manufacture or Shipping 76
Delivered as Unsterile Product 47
Manufacturing, Packaging or Shipping Problem 43
Component Misassembled 37
Detachment Of Device Component 36
Material Frayed 28
Packaging Problem 25
Appropriate Term/Code Not Available 24
Device Markings/Labelling Problem 24
Material Integrity Problem 24
Defective Component 18
Biocompatibility 17
Nonstandard Device 15
Unsealed Device Packaging 13
Insufficient Information 12

Yearly Trend

92
1992: 1
94
1994: 1
96
1996: 34
97
1997: 53
98
1998: 32
99
1999: 6
00
2000: 10
01
2001: 4
03
2003: 1
04
2004: 1
05
2005: 5
06
2006: 7
07
2007: 7
08
2008: 21
09
2009: 12
10
2010: 24
11
2011: 6
12
2012: 8
13
2013: 3
14
2014: 15
15
2015: 25
16
2016: 54
17
2017: 55
18
2018: 340
19
2019: 333
20
2020: 426
21
2021: 437
22
2022: 419
23
2023: 404
24
2024: 455
25
2025: 488
26
2026: 78

Related Entities for Suture, Nonabsorbable, Silk

Top Manufacturers

ETHICON INC. 2,901
DAVIS & GECK CARIBE LTD 278
UNITED STATES SURGICAL CORP. 76
ETHICON, INC. 66
COVIDIEN 18

Event Locations

2,083 (55.3%)
I 1,465 (38.9%)
HOSPITAL 160 (4.2%)
OTHER 23 (0.6%)
NO INFORMATION 17 (0.5%)
INVALID DATA 8 (0.2%)
UNKNOWN 6 (0.2%)
HOME 2 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare ETHICON INC. vs DAVIS & GECK CARIBE LTD →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Suture, Nonabsorbable, Silk, 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 (3,765 here).

Visual, Pregnancy Hcg, Prescription Use 3,737 File, Pulp Canal, Endodontic 3,734 Analyzer, Pacemaker Generator Function 3,813 Covid-19 Multi-Analyte Antigen Device 3,713

Similar death-typed counts

Nearest other device types by death-typed report count (8 here), distinct from the volume row.

Agent 8 Bronchoscope Accessory 8 Catheter, Balloon, Transcervical 8 Catheter, Nephrostomy 8

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

Disclaimer: MAUDE figures for Suture, Nonabsorbable, Silk 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, Nonabsorbable, Silk; 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.