2026 data FDA MAUDE openFDA

Impactor

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 MAUDE casebook

openFDA event book Impactor MID-BOOK · MAUDE

#143 of 1000 · 18,375 reports · 1994–2026

  • BOOK 18,375 reports
  • RANK #143 of 1000
  • DEATH 0 death-typed
  • INJ 351 injury-typed
  • MALF 17,997 malfunction
  • SPAN 1994–2026
  • PEAK 2023: 2,237
  • PHOTO Tube, Tracheal

Nearest event-volume peer: Tube, Tracheal (W/Wo Connector) (98 report gap)

Impactor sits #143 of 1000 among tracked device types with 18,375 MAUDE reports spanning 1994–2026. 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 1.9% corpus 30.4% · below corpus mean (-28.5 pp)
  • MALF 97.9% corpus 64.5% · above corpus mean (+33.4 pp)

Lead product-problem code Break is 65% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 37% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Impactor in the event-volume neighbourhood

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

reports

What this shows Impactor carries 18,375 MAUDE reports, ranked #143 of 1000.

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

Event Types

Malfunction 17,997 (97.9%)
Injury 351 (1.9%)
Other 20 (0.1%)
7 (0.0%)

Patient Outcomes

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

17,581 (95.5%)
Other 372 (2.0%)
Required Intervention 296 (1.6%)
Hospitalization 71 (0.4%)
R 62 (0.3%)
O 11 (0.1%)
H 5 (0.0%)
S 5 (0.0%)
Disability 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Break 12,605
Crack 1,477
Naturally Worn 1,008
Device-Device Incompatibility 995
Fracture 982
Material Deformation 561
Material Twisted/Bent 338
Contamination /Decontamination Problem 239
Scratched Material 230
No Apparent Adverse Event 175
Appropriate Term/Code Not Available 165
Material Integrity Problem 150
Mechanical Jam 115
Detachment of Device or Device Component 102
Unintended Movement 87
Adverse Event Without Identified Device or Use Problem 71
Component Missing 57
Loose or Intermittent Connection 52
Connection Problem 41
Illegible Information 41

Yearly Trend

94
1994: 2
96
1996: 17
97
1997: 39
98
1998: 29
99
1999: 12
00
2000: 19
01
2001: 9
02
2002: 14
03
2003: 1
04
2004: 9
05
2005: 13
06
2006: 7
07
2007: 18
08
2008: 65
09
2009: 121
10
2010: 113
11
2011: 82
12
2012: 47
13
2013: 61
14
2014: 89
15
2015: 112
16
2016: 857
17
2017: 1,404
18
2018: 1,609
19
2019: 1,550
20
2020: 1,477
21
2021: 2,006
22
2022: 2,086
23
2023: 2,237
24
2024: 2,008
25
2025: 1,939
26
2026: 323

Related Entities for Impactor

Event Locations

9,753 (53.1%)
I 8,359 (45.5%)
HOSPITAL 228 (1.2%)
NO INFORMATION 20 (0.1%)
INVALID DATA 6 (0.0%)
OTHER 5 (0.0%)
NOT APPLICABLE 3 (0.0%)
UNKNOWN 1 (0.0%)

Compare DEPUY ORTHOPAEDICS INC US vs DEPUY IRELAND - 9616671 →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Impactor, 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 (18,375 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 Impactor 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 Impactor; 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.