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2026 data FDA MAUDE openFDA

Template

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 Template MID-BOOK · MAUDE

#164 of 1000 · 15,801 reports · 1996–2026

  • BOOK 15,801 reports
  • RANK #164 of 1000
  • DEATH 0 death-typed
  • INJ 544 injury-typed
  • MALF 15,253 malfunction
  • SPAN 1996–2026
  • PEAK 2023: 2,598
  • PHOTO Fastener

Nearest event-volume peer: Fastener, Fixation, Biodegradable, Soft Tissue (153 report gap)

Template sits #164 of 1000 among tracked device types with 15,801 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 3.4% corpus 30.4% · below corpus mean (-27.0 pp)
  • MALF 96.5% corpus 64.5% · above corpus mean (+32.0 pp)

Lead product-problem code Break is 41% of coded problems · Lead manufacturer DEPUY IRELAND - 9616671 accounts for 44% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

Template in the event-volume neighbourhood

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

reports

What this shows Template carries 15,801 MAUDE reports, ranked #164 of 1000.

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

Event Types

Malfunction 15,253 (96.5%)
Injury 544 (3.4%)
2 (0.0%)
Other 2 (0.0%)

Patient Outcomes

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

14,896 (95.2%)
Required Intervention 411 (2.6%)
Other 172 (1.1%)
R 76 (0.5%)
Hospitalization 75 (0.5%)
O 7 (0.0%)
Disability 6 (0.0%)
H 4 (0.0%)
S 2 (0.0%)
L 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Death 1 (0.0%)

Top Product Problems

Break 7,757
Device-Device Incompatibility 1,826
Naturally Worn 1,684
Scratched Material 1,298
Crack 1,155
Detachment of Device or Device Component 977
Material Deformation 811
Fracture 585
Material Twisted/Bent 414
Illegible Information 400
Contamination /Decontamination Problem 346
Material Integrity Problem 250
No Apparent Adverse Event 225
Mechanical Jam 189
Peeled/Delaminated 168
Material Discolored 160
Component Missing 151
Appropriate Term/Code Not Available 140
Adverse Event Without Identified Device or Use Problem 108
Unintended Movement 92

Yearly Trend

96
1996: 3
97
1997: 1
98
1998: 2
99
1999: 2
01
2001: 3
03
2003: 3
06
2006: 3
08
2008: 5
10
2010: 62
11
2011: 2
12
2012: 20
13
2013: 88
14
2014: 78
15
2015: 93
16
2016: 444
17
2017: 651
18
2018: 714
19
2019: 741
20
2020: 938
21
2021: 2,177
22
2022: 2,096
23
2023: 2,598
24
2024: 2,416
25
2025: 2,252
26
2026: 409

Related Entities for Template

Top Manufacturers

DEPUY IRELAND - 9616671 6,276
DEPUY ORTHOPAEDICS INC US 4,921
DEPUY IRELAND - 3015516266 1,097
DEPUY ORTHOPAEDICS, INC. 422
ZIMMER BIOMET, INC. 420
DEPUY ORTHOPAEDICS, INC. 1818910 377
DEPUY IRELAND 9616671 321
SMITH & NEPHEW, INC. 257
DEPUY IRELAND 181
MICROPORT ORTHOPEDICS INC. 143

Event Locations

10,701 (67.7%)
I 5,077 (32.1%)
HOSPITAL 17 (0.1%)
NO INFORMATION 3 (0.0%)
OTHER 3 (0.0%)

Compare DEPUY IRELAND - 9616671 vs DEPUY ORTHOPAEDICS INC US →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Template, 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 (15,801 here).

Fastener 15,954 Catheter, Urological And Accessories 15,616 Prosthesis 15,610 Cardiac Ablation Percutaneous Catheter 15,997

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 Template 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 Template; 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.