2026 data FDA MAUDE openFDA FDA Class II

Suture, Nonabsorbable, Synthetic, Polyamide

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 §878.5020 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Suture, Nonabsorbable, Synthetic, Polyamide LIGHT-BOOK · MAUDE

#285 of 1000 · 6,091 reports · 1996–2026

  • BOOK 6,091 reports
  • RANK #285 of 1000
  • DEATH 2 death-typed
  • INJ 898 injury-typed
  • MALF 5,170 malfunction
  • SPAN 1996–2026
  • PEAK 2025: 829
  • PHOTO Dislodger

Nearest event-volume peer: Dislodger, Stone, Basket, Ureteral, Metal (12 report gap)

Suture, Nonabsorbable, Synthetic, Polyamide sits #285 of 1000 among tracked device types with 6,091 MAUDE reports spanning 1996–2026. 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, Synthetic, Polyamide carries 84.9% MALFUNCTION-coded reports, 20.1pp 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 14.7% corpus 30.3% · below corpus mean (-15.5 pp)
  • MALF 84.9% corpus 64.8% · above corpus mean (+20.1 pp)

Lead product-problem code Break is 45% of coded problems · Lead manufacturer ETHICON INC. accounts for 75% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

Suture, Nonabsorbable, Synthetic, Polyamide in the event-volume neighbourhood

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

reports

What this shows Suture, Nonabsorbable, Synthetic, Polyamide carries 6,091 MAUDE reports, ranked #285 of 1000.

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

Event Types

Malfunction 5,170 (84.9%)
Injury 898 (14.7%)
Other 14 (0.2%)
7 (0.1%)
Death 2 (0.0%)

Patient Outcomes

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

4,908 (80.4%)
Required Intervention 669 (11.0%)
Other 431 (7.1%)
R 40 (0.7%)
Hospitalization 31 (0.5%)
O 15 (0.2%)
Death 3 (0.0%)
H 2 (0.0%)
Life Threatening 2 (0.0%)
L 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Break 2,775
Material Separation 1,299
Adverse Event Without Identified Device or Use Problem 484
Detachment of Device or Device Component 348
Dull, Blunt 178
Material Split, Cut or Torn 133
Appropriate Device Problem Term/Code Not Available 115
Detachment Of Device Component 83
Product Quality Problem 82
Device Contaminated During Manufacture or Shipping 71
Device Markings/Labelling Problem 70
Other (for use when an appropriate device code cannot be identified) 68
Manufacturing, Packaging or Shipping Problem 63
Suture line disruption 63
Defective Component 62
Component Misassembled 59
Material Integrity Problem 52
Failure To Adhere Or Bond 42
Reaction 42
Delivered as Unsterile Product 39

Yearly Trend

96
1996: 12
97
1997: 51
98
1998: 7
99
1999: 13
00
2000: 11
01
2001: 12
02
2002: 18
03
2003: 6
04
2004: 22
05
2005: 12
06
2006: 10
07
2007: 18
08
2008: 14
09
2009: 12
10
2010: 39
11
2011: 8
12
2012: 5
13
2013: 42
14
2014: 103
15
2015: 86
16
2016: 124
17
2017: 180
18
2018: 541
19
2019: 518
20
2020: 384
21
2021: 532
22
2022: 549
23
2023: 607
24
2024: 668
25
2025: 829
26
2026: 658

Reports in 2025 (829) held close to the prior two-year average of 638.

Related Entities for Suture, Nonabsorbable, Synthetic, Polyamide

Event Locations

3,746 (61.5%)
I 2,109 (34.6%)
HOSPITAL 151 (2.5%)
OTHER 34 (0.6%)
UNKNOWN 31 (0.5%)
NO INFORMATION 14 (0.2%)
HOME 3 (0.0%)
OUTPATIENT TREATMENT FACILITY 3 (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, Synthetic, Polyamide: 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 (6,091 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Suture, Nonabsorbable, Synthetic, Polyamide 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, Synthetic, Polyamide; 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.