2026 data Public-data reference. official source

Pin, Fixation, Threaded

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Pin, Fixation, Threaded

The FDA MAUDE database aggregates 2,165 adverse-event reports for Pin, Fixation, Threaded spanning the period from 1992 through 2026. Of these, 2 are classified as death reports, 1,672 as injury reports, and 466 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 5 distinct event types and 10 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 Adverse Event Without Identified Device or Use Problem topping the list at 924 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 35 years of MAUDE data, with the peak single-year volume reaching 575 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 10 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.

2,165
Total Reports
2
Death Reports
1,672
Injury Reports
466
Malfunctions

Event Types

Injury 1,672 (77.2%)
Malfunction 466 (21.5%)
Other 19 (0.9%)
6 (0.3%)
Death 2 (0.1%)

Patient Outcomes

Required Intervention 1,032 (40.8%)
Other 423 (16.7%)
396 (15.7%)
R 293 (11.6%)
Hospitalization 291 (11.5%)
H 36 (1.4%)
O 32 (1.3%)
Disability 22 (0.9%)
S 3 (0.1%)
Death 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 924
Break 150
Fracture 89
Insufficient Information 87
Mechanical Problem 80
Patient Device Interaction Problem 69
Migration 42
Device Markings/Labelling Problem 23
Material Fragmentation 23
Material Deformation 20
Appropriate Term/Code Not Available 18
Loose or Intermittent Connection 16
Patient-Device Incompatibility 16
Malposition of Device 14
Device Dislodged or Dislocated 13
Device-Device Incompatibility 12
Loosening of Implant Not Related to Bone-Ingrowth 11
Dull, Blunt 9
Inadequacy of Device Shape and/or Size 8
Detachment of Device or Device Component 7

Yearly Trend

92
1992: 2
93
1993: 2
94
1994: 3
95
1995: 1
96
1996: 2
97
1997: 6
98
1998: 3
99
1999: 8
00
2000: 15
01
2001: 13
02
2002: 8
03
2003: 15
04
2004: 16
05
2005: 21
06
2006: 29
07
2007: 25
08
2008: 26
09
2009: 29
10
2010: 29
11
2011: 55
12
2012: 75
13
2013: 69
14
2014: 26
15
2015: 70
16
2016: 46
17
2017: 43
18
2018: 94
19
2019: 575
20
2020: 402
21
2021: 168
22
2022: 121
23
2023: 72
24
2024: 65
25
2025: 29
26
2026: 2

Related Entities for Pin, Fixation, Threaded

Event Locations

I 1,365 (63.0%)
664 (30.7%)
HOSPITAL 106 (4.9%)
OTHER 11 (0.5%)
AMBULATORY SURGICAL FACILITY 6 (0.3%)
NO INFORMATION 6 (0.3%)
HOME 2 (0.1%)
INVALID DATA 2 (0.1%)
OUTPATIENT TREATMENT FACILITY 2 (0.1%)
UNKNOWN 1 (0.0%)

Compare STRYKER GMBH vs SMITH & NEPHEW, 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.