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2026 data FDA MAUDE openFDA

Fastener, Fixation, Nondegradable, 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.

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FDA MAUDE casebook

openFDA event book Fastener MID-BOOK · MAUDE

#124 of 1000 · 23,725 reports · 1995–2026

  • BOOK 23,725 reports
  • RANK #124 of 1000
  • DEATH 5 death-typed
  • INJ 6,009 injury-typed
  • MALF 17,527 malfunction
  • SPAN 1995–2026
  • PEAK 2025: 3,876
  • PHOTO Programmer, Pacemaker

Nearest event-volume peer: Programmer, Pacemaker (2 report gap)

Fastener, Fixation, Nondegradable, Soft Tissue sits #124 of 1000 among tracked device types with 23,725 MAUDE reports spanning 1995–2026. 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 73.9% corpus 64.5% · above corpus mean (+9.4 pp)

Lead product-problem code Break is 38% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 29% of manufacturer-tagged reports · Top event location is 63% 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, Nondegradable, Soft Tissue carries 23,725 MAUDE reports, ranked #124 of 1000.

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

Event Types

Malfunction 17,527 (73.9%)
Injury 6,009 (25.3%)
Other 158 (0.7%)
26 (0.1%)
Death 5 (0.0%)

Patient Outcomes

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

16,977 (68.3%)
Other 3,178 (12.8%)
Required Intervention 2,890 (11.6%)
R 823 (3.3%)
Hospitalization 540 (2.2%)
O 237 (1.0%)
H 82 (0.3%)
S 55 (0.2%)
Disability 41 (0.2%)
Life Threatening 7 (0.0%)
Congenital Anomaly 5 (0.0%)
Death 4 (0.0%)

Top Product Problems

Break 6,892
Device-Device Incompatibility 1,771
Device Dislodged or Dislocated 1,277
Fracture 1,182
Adverse Event Without Identified Device or Use Problem 1,071
Detachment of Device or Device Component 706
Material Split, Cut or Torn 594
Premature Activation 489
Positioning Failure 485
Migration or Expulsion of Device 460
Physical Resistance/Sticking 417
Migration 412
Material Separation 373
Difficult to Advance 352
Insufficient Information 334
Material Deformation 331
Material Twisted/Bent 304
Failure to Advance 299
Material Fragmentation 279
Mechanical Jam 231

Yearly Trend

95
1995: 1
96
1996: 2
97
1997: 8
98
1998: 7
99
1999: 20
00
2000: 13
01
2001: 38
02
2002: 85
03
2003: 124
04
2004: 122
05
2005: 144
06
2006: 124
07
2007: 240
08
2008: 338
09
2009: 355
10
2010: 291
11
2011: 328
12
2012: 371
13
2013: 442
14
2014: 504
15
2015: 507
16
2016: 795
17
2017: 675
18
2018: 1,072
19
2019: 1,303
20
2020: 1,454
21
2021: 1,890
22
2022: 1,591
23
2023: 2,503
24
2024: 3,779
25
2025: 3,876
26
2026: 723

Related Entities for Fastener, Fixation, Nondegradable, Soft Tissue

Top Manufacturers

SMITH & NEPHEW, INC. 5,138
ARTHREX, INC. 4,629
MEDOS INTERNATIONAL SARL 2,355
ZIMMER BIOMET, INC. 1,391
DEPUY MITEK 1,259
STRYKER ENDOSCOPY-SAN JOSE 718
DEPUY MITEK LLC US 696
ARTHROCARE CORPORATION 693
ARTHROCARE CORP. 678

Event Locations

14,848 (62.6%)
I 6,486 (27.3%)
HOSPITAL 2,012 (8.5%)
AMBULATORY SURGICAL FACILITY 192 (0.8%)
NO INFORMATION 73 (0.3%)
OTHER 69 (0.3%)
UNKNOWN 12 (0.1%)
OUTPATIENT TREATMENT FACILITY 10 (0.0%)
NOT APPLICABLE 8 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 8 (0.0%)
HOME 3 (0.0%)
INVALID DATA 3 (0.0%)
AMBULATORY SURGICAL CENTER 1 (0.0%)

Compare SMITH & NEPHEW, INC. 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 (23,725 here).

Programmer, Pacemaker 23,727 Counter, Differential Cell 23,410 Thoracolumbosacral Pedicle Screw System 24,083 Stent, Coronary 23,266

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Anesthesia Conduction Kit 5 Antigens, All Groups, Streptococcus Spp. 5 Apparatus, Exhaust, Surgical 5 Bit, Drill 5

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.