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Extractor

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FDA MAUDE adverse event data · 1993–2026

What the Data Shows About Extractor

The FDA MAUDE database aggregates 3,381 adverse-event reports for Extractor spanning the period from 1993 through 2026. Of these, 0 are classified as death reports, 239 as injury reports, and 3,138 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 4 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 Break topping the list at 1,454 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 30 years of MAUDE data, with the peak single-year volume reaching 349 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.

3,381
Total Reports
0
Death Reports
239
Injury Reports
3,138
Malfunctions

Event Types

Malfunction 3,138 (92.8%)
Injury 239 (7.1%)
Other 3 (0.1%)
1 (0.0%)

Patient Outcomes

2,977 (88.2%)
Required Intervention 207 (6.1%)
Other 133 (3.9%)
Hospitalization 29 (0.9%)
R 17 (0.5%)
O 3 (0.1%)
S 3 (0.1%)
H 2 (0.1%)
Disability 2 (0.1%)
Life Threatening 1 (0.0%)

Top Product Problems

Break 1,454
Device-Device Incompatibility 484
Material Deformation 257
Material Twisted/Bent 250
Naturally Worn 158
Fracture 140
Mechanical Jam 81
Crack 74
Appropriate Term/Code Not Available 50
Bent 42
Material Integrity Problem 38
Material Fragmentation 32
No Apparent Adverse Event 26
Entrapment of Device 23
Scratched Material 20
Mechanical Problem 19
Adverse Event Without Identified Device or Use Problem 17
Corroded 17
Dull, Blunt 17
Physical Resistance/Sticking 15

Yearly Trend

93
1993: 1
96
1996: 12
97
1997: 13
98
1998: 16
99
1999: 4
01
2001: 2
03
2003: 2
04
2004: 1
05
2005: 3
06
2006: 4
07
2007: 9
08
2008: 37
09
2009: 60
10
2010: 19
11
2011: 15
12
2012: 9
13
2013: 106
14
2014: 71
15
2015: 78
16
2016: 162
17
2017: 239
18
2018: 286
19
2019: 320
20
2020: 302
21
2021: 322
22
2022: 319
23
2023: 349
24
2024: 285
25
2025: 291
26
2026: 44

Related Entities for Extractor

Event Locations

1,750 (51.8%)
I 1,548 (45.8%)
HOSPITAL 72 (2.1%)
INVALID DATA 4 (0.1%)
NO INFORMATION 4 (0.1%)
OTHER 2 (0.1%)
UNKNOWN 1 (0.0%)

Compare DEPUY ORTHOPAEDICS INC US vs DEPUY IRELAND - 9616671 →

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.