PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

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).

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FDA MAUDE casebook

openFDA event book Appliance LIGHT-BOOK · MAUDE

#687 of 1000 · 910 reports · 1992–2026

  • BOOK 910 reports
  • RANK #687 of 1000
  • DEATH 0 death-typed
  • INJ 617 injury-typed
  • MALF 283 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 123
  • PHOTO Device

Nearest event-volume peer: Device, Incontinence, Urosheath Type, Non-Sterile (1 report gap)

Appliance, Fixation, Nail/Blade/Plate Combination, Single Component sits #687 of 1000 among tracked device types with 910 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 67.8% INJURY-coded reports, 37.5pp 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 67.8% corpus 30.3% · above corpus mean (+37.5 pp)
  • MALF 31.1% corpus 64.8% · below corpus mean (-33.7 pp)

Lead product-problem code Break is 38% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 37% of manufacturer-tagged reports · Top event location is 71% 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, Single Component carries 910 MAUDE reports, ranked #687 of 1000.

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

Event Types

Injury 617 (67.8%)
Malfunction 283 (31.1%)
Other 6 (0.7%)
4 (0.4%)

Patient Outcomes

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

Required Intervention 481 (52.0%)
262 (28.3%)
Other 140 (15.1%)
Hospitalization 22 (2.4%)
R 12 (1.3%)
H 2 (0.2%)
O 2 (0.2%)
Invalid Data 2 (0.2%)
L 1 (0.1%)
S 1 (0.1%)

Top Product Problems

Break 343
Adverse Event Without Identified Device or Use Problem 160
Explanted 61
Patient Device Interaction Problem 48
Device Slipped 27
Fracture 27
Migration or Expulsion of Device 26
Insufficient Device Problem Information 25
Failure to Cut 21
Device Operates Differently Than Expected 20
Entrapment of Device 18
Device-Device Incompatibility 17
Replace 16
Device Dislodged or Dislocated 15
Positioning Failure 14
Fitting Problem 13
Implant, removal of 13
Material Twisted/Bent 13
Appropriate Device Problem Term/Code Not Available 11
Detachment Of Device Component 10

Yearly Trend

92
1992: 1
93
1993: 7
94
1994: 12
95
1995: 16
96
1996: 9
97
1997: 11
98
1998: 6
99
1999: 10
00
2000: 6
01
2001: 10
02
2002: 4
03
2003: 6
04
2004: 11
05
2005: 3
06
2006: 10
07
2007: 3
08
2008: 10
09
2009: 2
10
2010: 26
11
2011: 21
12
2012: 70
13
2013: 70
14
2014: 62
15
2015: 26
16
2016: 41
17
2017: 27
18
2018: 24
19
2019: 11
20
2020: 60
21
2021: 25
22
2022: 50
23
2023: 30
24
2024: 123
25
2025: 96
26
2026: 11

Reports in 2025 (96) held close to the prior two-year average of 77.

Related Entities for Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

Top Manufacturers

SYNTHES GMBH 221
ARTHREX, INC. 128
SYNTHES USA 88
SYNTHES (USA) 86
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 38
SYNTHES MONUMENT 30

Event Locations

642 (70.5%)
I 195 (21.4%)
HOSPITAL 44 (4.8%)
HOME 9 (1.0%)
INVALID DATA 7 (0.8%)
AMBULATORY SURGICAL FACILITY 4 (0.4%)
OTHER 3 (0.3%)
UNKNOWN 3 (0.3%)
NO INFORMATION 2 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare SYNTHES GMBH vs ARTHREX, 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 (910 here).

Device 909 Implant, Fixation Device, Spinal 909 Passer 906 Enzyme Immunoassay, Diphenylhydantoin 905

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 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.