PlainHospital
2026 data FDA MAUDE openFDA

Fastener, Fixation, Biodegradable, Soft Tissue

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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Fastener MID-BOOK · MAUDE

#163 of 1000 · 15,954 reports · 1996–2026

  • BOOK 15,954 reports
  • RANK #163 of 1000
  • DEATH 0 death-typed
  • INJ 4,036 injury-typed
  • MALF 11,509 malfunction
  • SPAN 1996–2026
  • PEAK 2024: 2,300
  • PHOTO Cardiac Ablation Perc…

Nearest event-volume peer: Cardiac Ablation Percutaneous Catheter (43 report gap)

Fastener, Fixation, Biodegradable, Soft Tissue sits #163 of 1000 among tracked device types with 15,954 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 25.3% corpus 30.4% · below corpus mean (-5.1 pp)
  • MALF 72.1% corpus 64.5% · above corpus mean (+7.6 pp)

Lead product-problem code Break is 60% of coded problems · Lead manufacturer DEPUY MITEK LLC US accounts for 45% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .

Fastener in the event-volume neighbourhood

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

reports

What this shows Fastener, Fixation, Biodegradable, Soft Tissue carries 15,954 MAUDE reports, ranked #163 of 1000.

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

Event Types

Malfunction 11,509 (72.1%)
Injury 4,036 (25.3%)
Other 384 (2.4%)
25 (0.2%)

Patient Outcomes

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

11,665 (72.0%)
Other 2,305 (14.2%)
Required Intervention 1,843 (11.4%)
R 193 (1.2%)
O 86 (0.5%)
Hospitalization 61 (0.4%)
S 15 (0.1%)
H 8 (0.0%)
Disability 8 (0.0%)
Life Threatening 6 (0.0%)
Death 4 (0.0%)
L 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Break 8,079
Adverse Event Without Identified Device or Use Problem 1,057
Device-Device Incompatibility 524
Migration 402
Crack 400
Detachment of Device or Device Component 371
Device Dislodged or Dislocated 347
Material Deformation 337
Fracture 273
Positioning Failure 214
Patient Device Interaction Problem 203
Difficult to Advance 189
Migration or Expulsion of Device 181
Material Twisted/Bent 165
Premature Activation 164
Failure to Advance 133
Material Separation 128
Insufficient Information 127
Activation, Positioning or Separation Problem 116
Material Split, Cut or Torn 116

Yearly Trend

96
1996: 1
97
1997: 1
98
1998: 1
99
1999: 43
00
2000: 49
01
2001: 21
02
2002: 87
03
2003: 35
04
2004: 106
05
2005: 94
06
2006: 150
07
2007: 272
08
2008: 172
09
2009: 88
10
2010: 89
11
2011: 129
12
2012: 171
13
2013: 166
14
2014: 149
15
2015: 182
16
2016: 301
17
2017: 478
18
2018: 1,590
19
2019: 1,248
20
2020: 957
21
2021: 1,267
22
2022: 1,425
23
2023: 1,718
24
2024: 2,300
25
2025: 2,180
26
2026: 484

Related Entities for Fastener, Fixation, Biodegradable, Soft Tissue

Top Manufacturers

DEPUY MITEK LLC US 6,532
ARTHREX, INC. 4,124
SMITH & NEPHEW, INC. 2,069
DEPUY MITEK 1,032
MEDOS INTERNATIONAL SARL 473
ARTHREX, INC. 145
ARTHREX INC. 93

Event Locations

9,699 (60.8%)
I 5,063 (31.7%)
HOSPITAL 1,060 (6.6%)
AMBULATORY SURGICAL FACILITY 50 (0.3%)
NO INFORMATION 21 (0.1%)
OTHER 21 (0.1%)
UNKNOWN 20 (0.1%)
HOME 6 (0.0%)
OUTPATIENT TREATMENT FACILITY 6 (0.0%)
INVALID DATA 5 (0.0%)
AMBULATORY SURGICAL CENTER 1 (0.0%)
IN TRANSIT TO USER/MEDICAL FACILITY 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare DEPUY MITEK LLC US vs ARTHREX, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Fastener, 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 (15,954 here).

Cardiac Ablation Percutaneous Catheter 15,997 Template 15,801 Applier, Surgical, Clip 16,148 System, Appendage Closure, Left Atrial 16,214

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Fastener 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 Fastener; 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.