2026 data FDA MAUDE openFDA FDA Class I

Apparatus, Traction, Non-Powered

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 §888.5850 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Apparatus, Traction, Non-Powered LIGHT-BOOK · MAUDE

#877 of 1000 · 519 reports · 1992–2026

  • BOOK 519 reports
  • RANK #877 of 1000
  • DEATH 3 death-typed
  • INJ 88 injury-typed
  • MALF 421 malfunction
  • SPAN 1992–2026
  • PEAK 2013: 49
  • PHOTO System

Nearest event-volume peer: System, Test, Rheumatoid Factor (1 report gap)

Apparatus, Traction, Non-Powered sits #877 of 1000 among tracked device types with 519 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 →

Malfunction reports run above the device-type norm

Apparatus, Traction, Non-Powered carries 81.1% MALFUNCTION-coded reports, 16.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 17.0% corpus 30.3% · below corpus mean (-13.3 pp)
  • MALF 81.1% corpus 64.8% · above corpus mean (+16.3 pp)

Lead product-problem code Break is 26% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 24% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Apparatus, Traction, Non-Powered in the event-volume neighbourhood

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

reports

What this shows Apparatus, Traction, Non-Powered carries 519 MAUDE reports, ranked #877 of 1000.

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

Event Types

Malfunction 421 (81.1%)
Injury 88 (17.0%)
Other 5 (1.0%)
Death 3 (0.6%)
2 (0.4%)

Patient Outcomes

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

399 (75.9%)
Other 56 (10.6%)
Required Intervention 48 (9.1%)
Hospitalization 7 (1.3%)
S 3 (0.6%)
Death 3 (0.6%)
Disability 3 (0.6%)
H 2 (0.4%)
O 2 (0.4%)
R 2 (0.4%)
Life Threatening 1 (0.2%)

Top Product Problems

Break 116
Device Operates Differently Than Expected 40
Device-Device Incompatibility 30
Adverse Event Without Identified Device or Use Problem 27
Mechanical Jam 26
Unintended Movement 22
Detachment Of Device Component 19
Fitting Problem 18
Positioning Failure 17
Detachment of Device or Device Component 15
Failure To Adhere Or Bond 14
Failure to Align 13
Use of Device Problem 13
Device Slipped 12
Material Twisted/Bent 12
Mechanical Problem 12
Material Deformation 10
Patient Device Interaction Problem 10
Sticking 10
Defective Device 9

Yearly Trend

92
1992: 2
93
1993: 1
94
1994: 1
96
1996: 3
97
1997: 1
98
1998: 1
99
1999: 1
00
2000: 2
01
2001: 2
02
2002: 6
03
2003: 3
04
2004: 4
05
2005: 3
06
2006: 4
07
2007: 1
08
2008: 4
09
2009: 28
10
2010: 2
11
2011: 1
12
2012: 5
13
2013: 49
14
2014: 38
15
2015: 37
16
2016: 28
17
2017: 20
18
2018: 25
19
2019: 32
20
2020: 37
21
2021: 40
22
2022: 26
23
2023: 18
24
2024: 47
25
2025: 20
26
2026: 27

Reports fell to 20 in 2025, down from an average of 33 in the two years before.

Related Entities for Apparatus, Traction, Non-Powered

Event Locations

286 (55.1%)
I 179 (34.5%)
HOSPITAL 30 (5.8%)
NO INFORMATION 8 (1.5%)
HOME 4 (0.8%)
UNKNOWN 4 (0.8%)
AMBULATORY SURGICAL FACILITY 2 (0.4%)
INVALID DATA 2 (0.4%)
NURSING HOME 2 (0.4%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Compare SMITH & NEPHEW, INC. vs SYNTHES BRANDYWINE →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Apparatus, Traction, Non-Powered: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (519 here).

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Disclaimer: MAUDE figures for Apparatus, Traction, Non-Powered 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 Apparatus, Traction, Non-Powered; 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.