PlainHospital
2026 data FDA MAUDE openFDA FDA Class I

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

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Impactor MID-BOOK · MAUDE

#146 of 1000 · 19,287 reports · 1994–2026

  • BOOK 19,287 reports
  • RANK #146 of 1000
  • DEATH 0 death-typed
  • INJ 353 injury-typed
  • MALF 18,907 malfunction
  • SPAN 1994–2026
  • PEAK 2023: 2,237
  • PHOTO Tube, Tracheal

Nearest event-volume peer: Tube, Tracheal (W/Wo Connector) (192 report gap)

Impactor sits #146 of 1000 among tracked device types with 19,287 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 →

Malfunction reports run above the device-type norm

Impactor carries 98.0% MALFUNCTION-coded reports, 33.2pp 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 1.8% corpus 30.3% · below corpus mean (-28.5 pp)
  • MALF 98.0% corpus 64.8% · above corpus mean (+33.2 pp)

Lead product-problem code Break is 64% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 37% of manufacturer-tagged reports · Top event location is 55% 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 19,287 MAUDE reports, ranked #146 of 1000.

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

Event Types

Malfunction 18,907 (98.0%)
Injury 353 (1.8%)
Other 20 (0.1%)
7 (0.0%)

Patient Outcomes

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

18,339 (95.7%)
Other 376 (2.0%)
Required Intervention 298 (1.6%)
Hospitalization 72 (0.4%)
R 63 (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 13,470
Crack 1,549
Fracture 1,177
Device-Device Incompatibility 1,157
Naturally Worn 1,012
Material Deformation 718
Material Twisted/Bent 340
Contamination /Decontamination Problem 270
Scratched Material 242
No Apparent Adverse Event 194
Appropriate Device Problem Term/Code Not Available 169
Material Integrity Problem 161
Mechanical Jam 136
Detachment of Device or Device Component 119
Unintended Movement 97
Detachment Of Device Component 91
Adverse Event Without Identified Device or Use Problem 74
Component Missing 64
Loose or Intermittent Connection 57
Material Fragmentation 55

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: 1,235

Reports in 2025 (1,939) held close to the prior two-year average of 2,123.

Related Entities for Impactor

Top Manufacturers

DEPUY ORTHOPAEDICS INC US 6,284
DEPUY IRELAND - 9616671 5,429
DEPUY ORTHOPAEDICS, INC. 1,117
DEPUY IRELAND - 3015516266 1,020
DEPUY ORTHOPAEDICS, INC. 1818910 970
DEPUY IRELAND 9616671 748
ZIMMER BIOMET, INC. 544
SMITH & NEPHEW, INC. 330
ZIMMER, INC. 227
DEPUY INTERNATIONAL LTD - 8010379 199

Event Locations

10,667 (55.3%)
I 8,357 (43.3%)
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 a comparable report-volume footprint

Impactor 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 (19,287 here).

Tube, Tracheal 19,095 System, Image Processing, Radiological 19,647 Suture 19,686 Dorsal Root Ganglion Stimulator For Pain Re… 19,735

Similar death-typed counts

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

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

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.