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2026 data FDA MAUDE openFDA FDA Class II

Suture, Nonabsorbable, Synthetic, Polypropylene

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 §878.5010 (General, Plastic Surgery panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Suture MID-BOOK · MAUDE

#144 of 1000 · 19,686 reports · 1992–2026

  • BOOK 19,686 reports
  • RANK #144 of 1000
  • DEATH 226 death-typed
  • INJ 3,451 injury-typed
  • MALF 15,929 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 2,583
  • PHOTO System

Nearest event-volume peer: System, Image Processing, Radiological (39 report gap)

Suture, Nonabsorbable, Synthetic, Polypropylene sits #144 of 1000 among tracked device types with 19,686 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 carries 80.9% MALFUNCTION-coded reports, 16.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
  • INJ 17.5% corpus 30.3% · below corpus mean (-12.8 pp)
  • MALF 80.9% corpus 64.8% · above corpus mean (+16.1 pp)

Lead product-problem code Break is 45% of coded problems · Lead manufacturer ETHICON INC. accounts for 76% of manufacturer-tagged reports · Top event location is 59% 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, Synthetic, Polypropylene carries 19,686 MAUDE reports, ranked #144 of 1000.

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

Event Types

Malfunction 15,929 (80.9%)
Injury 3,451 (17.5%)
Death 226 (1.1%)
47 (0.2%)
Other 33 (0.2%)

Patient Outcomes

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

14,965 (75.7%)
Required Intervention 2,600 (13.1%)
Other 1,542 (7.8%)
Death 197 (1.0%)
R 186 (0.9%)
Hospitalization 121 (0.6%)
O 39 (0.2%)
Life Threatening 34 (0.2%)
H 26 (0.1%)
D 25 (0.1%)
L 16 (0.1%)
S 10 (0.1%)
Disability 6 (0.0%)
Invalid Data 3 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Break 9,004
Material Separation 4,495
Adverse Event Without Identified Device or Use Problem 1,604
Detachment of Device or Device Component 1,061
Material Frayed 938
Suture line disruption 381
Failure To Adhere Or Bond 374
Material Split, Cut or Torn 322
Needle, separation 226
Material Integrity Problem 211
Detachment Of Device Component 191
Replace 191
Other (for use when an appropriate device code cannot be identified) 184
Appropriate Device Problem Term/Code Not Available 175
Insufficient Device Problem Information 156
Device Contaminated During Manufacture or Shipping 137
Material Twisted/Bent 112
Device Markings/Labelling Problem 106
Suture line separation 100
Device Operates Differently Than Expected 95

Yearly Trend

92
1992: 1
93
1993: 6
94
1994: 13
95
1995: 9
96
1996: 71
97
1997: 427
98
1998: 380
99
1999: 200
00
2000: 123
01
2001: 124
02
2002: 150
03
2003: 88
04
2004: 38
05
2005: 39
06
2006: 56
07
2007: 73
08
2008: 75
09
2009: 71
10
2010: 85
11
2011: 84
12
2012: 194
13
2013: 191
14
2014: 437
15
2015: 422
16
2016: 440
17
2017: 413
18
2018: 685
19
2019: 1,803
20
2020: 1,493
21
2021: 1,652
22
2022: 1,563
23
2023: 1,811
24
2024: 2,348
25
2025: 2,583
26
2026: 1,538

Reports in 2025 (2,583) held close to the prior two-year average of 2,080.

Related Entities for Suture, Nonabsorbable, Synthetic, Polypropylene

Top Manufacturers

ETHICON INC. 13,068
DAVIS & GECK CARIBE LTD 1,625
ETHICON, INC. 778
B. BRAUN SURGICAL, S.A. 582
B. BRAUN SURGICAL S.A. 338
TELEFLEX MEDICAL 272
UNITED STATES SURGICAL CORP. 229
W.L. GORE & ASSOCIATES 195

Event Locations

11,536 (58.6%)
I 6,168 (31.3%)
HOSPITAL 1,623 (8.2%)
OTHER 106 (0.5%)
UNKNOWN 82 (0.4%)
INVALID DATA 75 (0.4%)
NO INFORMATION 59 (0.3%)
HOME 22 (0.1%)
AMBULATORY SURGICAL FACILITY 5 (0.0%)
OPERATING ROOM 3 (0.0%)
CRITICAL CARE UNIT 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)
NOT APPLICABLE 1 (0.0%)
PATIENT'S ROOM OR WARD 1 (0.0%)
REHABILITATION CENTER 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: 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 (19,686 here).

System, Image Processing, Radiological 19,647 Dorsal Root Ganglion Stimulator For Pain Re… 19,735 Leadless Pacemaker 19,964 Suture 20,010

Similar death-typed counts

Nearest other device types by death-typed report count (226 here), distinct from the volume row.

Integrated Continuous Glucose Monitoring Sy… 226 System, Hemodynamic, Implantable 226 Pump, Infusion, Pca 225 Shunt, Central Nervous System And Components 222

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.