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2026 data FDA MAUDE openFDA

Suture, Absorbable, Synthetic

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, Absorbable, Synthetic LIGHT-BOOK · MAUDE

#298 of 1000 · 5,414 reports · 1992–2026

  • BOOK 5,414 reports
  • RANK #298 of 1000
  • DEATH 8 death-typed
  • INJ 1,944 injury-typed
  • MALF 3,452 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 450
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (23 report gap)

Suture, Absorbable, Synthetic sits #298 of 1000 among tracked device types with 5,414 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 35.9% corpus 30.4% · above corpus mean (+5.5 pp)
  • MALF 63.8% corpus 64.5% · below corpus mean (-0.7 pp)

Lead product-problem code Break is 40% of coded problems · Lead manufacturer ETHICON INC. accounts for 72% of manufacturer-tagged reports · Top event location is 41% of location-tagged rows .

Suture, Absorbable, Synthetic in the event-volume neighbourhood

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

reports

What this shows Suture, Absorbable, Synthetic carries 5,414 MAUDE reports, ranked #298 of 1000.

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

Event Types

Malfunction 3,452 (63.8%)
Injury 1,944 (35.9%)
Death 8 (0.1%)
7 (0.1%)
Other 3 (0.1%)

Patient Outcomes

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

3,481 (63.3%)
Required Intervention 1,461 (26.6%)
Other 378 (6.9%)
Hospitalization 77 (1.4%)
R 74 (1.3%)
Death 7 (0.1%)
Life Threatening 6 (0.1%)
S 4 (0.1%)
L 3 (0.1%)
O 3 (0.1%)
Disability 2 (0.0%)

Top Product Problems

Break 1,308
Material Separation 872
Adverse Event Without Identified Device or Use Problem 584
Appropriate Term/Code Not Available 138
Detachment Of Device Component 80
Material Integrity Problem 57
Tear, Rip or Hole in Device Packaging 44
Material Frayed 40
Component Misassembled 38
Detachment of Device or Device Component 24
Device Markings/Labelling Problem 21
Defective Component 17
Positioning Failure 15
Product Quality Problem 14
Delivered as Unsterile Product 12
Insufficient Information 12
Material Twisted/Bent 11
Component Incompatible 10
Component Missing 7
Unsealed Device Packaging 7

Yearly Trend

92
1992: 2
94
1994: 6
95
1995: 12
96
1996: 156
97
1997: 381
98
1998: 128
99
1999: 123
00
2000: 111
01
2001: 131
02
2002: 168
03
2003: 61
04
2004: 51
05
2005: 67
06
2006: 72
07
2007: 86
08
2008: 124
09
2009: 67
10
2010: 23
11
2011: 62
12
2012: 157
13
2013: 103
14
2014: 92
15
2015: 76
16
2016: 63
17
2017: 67
18
2018: 400
19
2019: 434
20
2020: 278
21
2021: 301
22
2022: 327
23
2023: 343
24
2024: 450
25
2025: 423
26
2026: 69

Related Entities for Suture, Absorbable, Synthetic

Top Manufacturers

ETHICON INC. 3,344
ETHICON, INC. 562
UNITED STATES SURGICAL CORP. 524
UNITED STATES SURGICAL CORPORATION 100
NORTH HAVEN - USS 81
UNITED STATES SURGICAL CORP 35

Event Locations

2,236 (41.3%)
I 1,488 (27.5%)
HOSPITAL 1,259 (23.3%)
OTHER 241 (4.5%)
UNKNOWN 134 (2.5%)
HOME 20 (0.4%)
INVALID DATA 19 (0.4%)
NO INFORMATION 6 (0.1%)
AMBULATORY SURGICAL FACILITY 3 (0.1%)
OUTPATIENT TREATMENT FACILITY 3 (0.1%)
OPERATING ROOM 2 (0.0%)
NURSING HOME 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
REHABILITATION CENTER 1 (0.0%)

Compare ETHICON INC. vs ETHICON, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Suture, Absorbable, Synthetic, 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 (5,414 here).

Prosthesis 5,391 Catheter, Irrigation 5,333 Stopcock, I.V. Set 5,518 Prosthesis 5,290

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, Absorbable, Synthetic 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, Absorbable, Synthetic; 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.