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Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

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FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

The FDA MAUDE database aggregates 777 adverse-event reports for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite spanning the period from 1992 through 2026. Of these, 0 are classified as death reports, 473 as injury reports, and 301 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 3 distinct event types and 8 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Break topping the list at 49 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 27 years of MAUDE data, with the peak single-year volume reaching 85 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 7 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

777
Total Reports
0
Death Reports
473
Injury Reports
301
Malfunctions

Event Types

Injury 473 (60.9%)
Malfunction 301 (38.7%)
Other 3 (0.4%)

Patient Outcomes

Required Intervention 387 (45.4%)
257 (30.1%)
Hospitalization 73 (8.6%)
R 72 (8.4%)
Other 58 (6.8%)
H 3 (0.4%)
O 2 (0.2%)
Disability 1 (0.1%)

Top Product Problems

Break 49
Mechanical Problem 45
Adverse Event Without Identified Device or Use Problem 42
Packaging Problem 24
Manufacturing, Packaging or Shipping Problem 23
Insufficient Information 17
Device-Device Incompatibility 16
Migration 15
Difficult to Insert 14
Malposition of Device 14
Appropriate Term/Code Not Available 12
Crack 9
Device Contaminated During Manufacture or Shipping 9
Migration or Expulsion of Device 9
Fracture 8
Physical Property Issue 7
Component Missing 5
Connection Problem 5
Device Contamination with Chemical or Other Material 5
Device Markings/Labelling Problem 5

Yearly Trend

92
1992: 1
00
2000: 2
01
2001: 3
02
2002: 9
03
2003: 6
04
2004: 1
06
2006: 12
07
2007: 26
08
2008: 58
09
2009: 41
10
2010: 33
11
2011: 85
12
2012: 42
13
2013: 39
14
2014: 36
15
2015: 35
16
2016: 38
17
2017: 66
18
2018: 73
19
2019: 40
20
2020: 32
21
2021: 24
22
2022: 21
23
2023: 18
24
2024: 27
25
2025: 7
26
2026: 2

Related Entities for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Event Locations

480 (61.8%)
I 275 (35.4%)
HOSPITAL 16 (2.1%)
HOME 2 (0.3%)
NO INFORMATION 2 (0.3%)
OTHER 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare ZIMMER BIOMET, INC. vs DEPUY ORTHOPAEDICS, INC. →

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.