2026 data FDA MAUDE openFDA FDA Class II

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

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 II (moderate risk, special controls required), regulated under 21 CFR §888.3030 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Appliance LIGHT-BOOK · MAUDE

#742 of 1000 · 779 reports · 1992–2026

  • BOOK 779 reports
  • RANK #742 of 1000
  • DEATH 0 death-typed
  • INJ 474 injury-typed
  • MALF 302 malfunction
  • SPAN 1992–2026
  • PEAK 2011: 85
  • PHOTO Computer

Nearest event-volume peer: Computer, Diagnostic, Pre-Programmed, Single-Function (1 report gap)

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite sits #742 of 1000 among tracked device types with 779 MAUDE reports spanning 1992–2026. 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 →

Injury-coded reports run above the device-type norm

Appliance carries 60.8% INJURY-coded reports, 30.6pp 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 60.8% corpus 30.3% · above corpus mean (+30.6 pp)
  • MALF 38.8% corpus 64.8% · below corpus mean (-26.1 pp)

Lead product-problem code Break is 18% of coded problems · Lead manufacturer ZIMMER BIOMET, INC. accounts for 37% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

Appliance in the event-volume neighbourhood

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

reports

What this shows Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite carries 779 MAUDE reports, ranked #742 of 1000.

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

Event Types

Injury 474 (60.8%)
Malfunction 302 (38.8%)
Other 3 (0.4%)

Patient Outcomes

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

Required Intervention 389 (45.4%)
258 (30.1%)
Hospitalization 73 (8.5%)
R 72 (8.4%)
Other 58 (6.8%)
H 3 (0.4%)
O 2 (0.2%)
Disability 1 (0.1%)

Top Product Problems

Break 134
Implant, removal of 90
Insufficient Device Problem Information 66
Mechanical Problem 54
Adverse Event Without Identified Device or Use Problem 50
Appropriate Device Problem Term/Code Not Available 46
Difficult to Insert 46
Unknown (for use when the device problem is not known) 37
Fracture 31
Packaging Problem 27
Replace 24
Manufacturing, Packaging or Shipping Problem 23
Explanted 21
Migration or Expulsion of Device 19
Device Slipped 17
Malposition of Device 17
Device Operates Differently Than Expected 16
Device-Device Incompatibility 16
Migration 15
Malfunction 14

Yearly Trend

92
1992: 1
00
2000: 2
01
2001: 3
02
2002: 9
03
2003: 6
04
2004: 1
06
2006: 12
07
2007: 26
08
2008: 58
09
2009: 41
10
2010: 33
11
2011: 85
12
2012: 42
13
2013: 39
14
2014: 36
15
2015: 35
16
2016: 38
17
2017: 66
18
2018: 73
19
2019: 40
20
2020: 32
21
2021: 24
22
2022: 21
23
2023: 18
24
2024: 27
25
2025: 7
26
2026: 4

Reports fell to 7 in 2025, down from an average of 23 in the two years before.

Related Entities for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Event Locations

482 (61.9%)
I 275 (35.3%)
HOSPITAL 16 (2.1%)
HOME 2 (0.3%)
NO INFORMATION 2 (0.3%)
OTHER 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare ZIMMER BIOMET, INC. vs DEPUY ORTHOPAEDICS, INC. →

Nationwide devices with a comparable report-volume footprint

Appliance 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 (779 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 Appliance 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 Appliance; 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.