2026 data FDA MAUDE openFDA

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 MAUDE casebook

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

#292 of 1000 · 5,613 reports · 1996–2026

  • BOOK 5,613 reports
  • RANK #292 of 1000
  • DEATH 2 death-typed
  • INJ 839 injury-typed
  • MALF 4,751 malfunction
  • SPAN 1996–2026
  • PEAK 2025: 831
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer (4 report gap)

Suture, Nonabsorbable, Synthetic, Polyamide sits #292 of 1000 among tracked device types with 5,613 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 →

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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 14.9% corpus 30.4% · below corpus mean (-15.5 pp)
  • MALF 84.6% corpus 64.5% · above corpus mean (+20.1 pp)

Lead product-problem code Break is 46% of coded problems · Lead manufacturer ETHICON INC. accounts for 80% of manufacturer-tagged reports · Top event location is 58% 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 5,613 MAUDE reports, ranked #292 of 1000.

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

Event Types

Malfunction 4,751 (84.6%)
Injury 839 (14.9%)
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.

4,523 (80.0%)
Required Intervention 627 (11.1%)
Other 412 (7.3%)
R 40 (0.7%)
Hospitalization 30 (0.5%)
O 15 (0.3%)
Death 3 (0.1%)
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 2,429
Material Separation 1,155
Adverse Event Without Identified Device or Use Problem 430
Detachment of Device or Device Component 328
Material Split, Cut or Torn 124
Appropriate Term/Code Not Available 113
Dull, Blunt 97
Product Quality Problem 70
Detachment Of Device Component 66
Device Markings/Labelling Problem 63
Manufacturing, Packaging or Shipping Problem 61
Defective Component 60
Device Contaminated During Manufacture or Shipping 57
Component Misassembled 55
Material Integrity Problem 52
Delivered as Unsterile Product 37
Failure To Adhere Or Bond 29
Material Frayed 28
Material Discolored 25
Material Twisted/Bent 22

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: 831
26
2026: 178

Related Entities for Suture, Nonabsorbable, Synthetic, Polyamide

Event Locations

3,270 (58.3%)
I 2,109 (37.6%)
HOSPITAL 149 (2.7%)
OTHER 34 (0.6%)
UNKNOWN 31 (0.6%)
NO INFORMATION 14 (0.2%)
HOME 3 (0.1%)
OUTPATIENT TREATMENT FACILITY 3 (0.1%)

Compare ETHICON INC. vs DAVIS & GECK CARIBE LTD →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Suture, Nonabsorbable, Synthetic, Polyamide, 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 (5,613 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.