2026 data FDA MAUDE openFDA FDA Class I

Extractor

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.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §888.4540 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Extractor LIGHT-BOOK · MAUDE

#372 of 1000 · 3,487 reports · 1993–2026

  • BOOK 3,487 reports
  • RANK #372 of 1000
  • DEATH 0 death-typed
  • INJ 242 injury-typed
  • MALF 3,241 malfunction
  • SPAN 1993–2026
  • PEAK 2023: 349
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Hypoglossal Nerve, Implanted, Apnea (1 report gap)

Extractor sits #372 of 1000 among tracked device types with 3,487 MAUDE reports spanning 1993–2026. 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 →

Malfunction reports run above the device-type norm

Extractor carries 92.9% MALFUNCTION-coded reports, 28.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 6.9% corpus 30.3% · below corpus mean (-23.4 pp)
  • MALF 92.9% corpus 64.8% · above corpus mean (+28.1 pp)

Lead product-problem code Break is 47% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 33% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Extractor in the event-volume neighbourhood

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

reports

What this shows Extractor carries 3,487 MAUDE reports, ranked #372 of 1000.

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

Event Types

Malfunction 3,241 (92.9%)
Injury 242 (6.9%)
Other 3 (0.1%)
1 (0.0%)

Patient Outcomes

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

3,086 (88.4%)
Required Intervention 210 (6.0%)
Other 136 (3.9%)
Hospitalization 29 (0.8%)
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 1,757
Device-Device Incompatibility 507
Material Deformation 281
Material Twisted/Bent 262
Fracture 190
Naturally Worn 165
Mechanical Jam 92
Crack 77
Difficult to Remove 60
Appropriate Device Problem Term/Code Not Available 56
Bent 49
Material Fragmentation 43
Material Integrity Problem 43
No Apparent Adverse Event 34
Detachment Of Device Component 27
Device Operates Differently Than Expected 27
Entrapment of Device 27
Scratched Material 21
Corroded 20
Mechanical Problem 20

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: 150

Reports in 2025 (291) held close to the prior two-year average of 317.

Related Entities for Extractor

Event Locations

1,856 (53.2%)
I 1,548 (44.4%)
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 →

Nationwide devices with a comparable report-volume footprint

Extractor carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (3,487 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Extractor 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 Extractor; 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.