2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §878.5030 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Suture, Nonabsorbable, Silk LIGHT-BOOK · MAUDE

#354 of 1000 · 3,979 reports · 1992–2026

  • BOOK 3,979 reports
  • RANK #354 of 1000
  • DEATH 8 death-typed
  • INJ 777 injury-typed
  • MALF 3,185 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 488
  • PHOTO Orthosis

Nearest event-volume peer: Orthosis, Spinal Pedicle Fixation (10 report gap)

Suture, Nonabsorbable, Silk sits #354 of 1000 among tracked device types with 3,979 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 →

Malfunction reports run above the device-type norm

Suture, Nonabsorbable, Silk carries 80.0% MALFUNCTION-coded reports, 15.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 19.5% corpus 30.3% · below corpus mean (-10.8 pp)
  • MALF 80.0% corpus 64.8% · above corpus mean (+15.2 pp)

Lead product-problem code Break is 54% of coded problems · Lead manufacturer ETHICON INC. accounts for 83% of manufacturer-tagged reports · Top event location is 58% 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 3,979 MAUDE reports, ranked #354 of 1000.

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

Event Types

Malfunction 3,185 (80.0%)
Injury 777 (19.5%)
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.

3,103 (78.1%)
Required Intervention 631 (15.9%)
Other 191 (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 2,107
Adverse Event Without Identified Device or Use Problem 559
Material Separation 397
Detachment of Device or Device Component 172
Material Split, Cut or Torn 105
Device Contaminated During Manufacture or Shipping 93
Suture line disruption 77
Detachment Of Device Component 49
Delivered as Unsterile Product 48
Manufacturing, Packaging or Shipping Problem 45
Component Misassembled 38
Product Quality Problem 36
Material Frayed 34
Appropriate Device Problem Term/Code Not Available 28
Material Integrity Problem 28
Device Markings/Labelling Problem 27
Packaging Problem 26
Defective Component 18
Biocompatibility 17
Insufficient Device Problem Information 17

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: 292

Reports in 2025 (488) held close to the prior two-year average of 430.

Related Entities for Suture, Nonabsorbable, Silk

Event Locations

2,297 (57.7%)
I 1,465 (36.8%)
HOSPITAL 160 (4.0%)
OTHER 23 (0.6%)
NO INFORMATION 17 (0.4%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Suture, Nonabsorbable, Silk: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (3,979 here).

Similar death-typed counts

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

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.