2026 data FDA MAUDE openFDA FDA Class II

Pin, Fixation, Threaded

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 §888.3040 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Pin, Fixation, Threaded LIGHT-BOOK · MAUDE

#476 of 1000 · 2,172 reports · 1992–2026

  • BOOK 2,172 reports
  • RANK #476 of 1000
  • DEATH 2 death-typed
  • INJ 1,676 injury-typed
  • MALF 469 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 575
  • PHOTO Catheter, Subclavian

Nearest event-volume peer: Catheter, Subclavian (2 report gap)

Pin, Fixation, Threaded sits #476 of 1000 among tracked device types with 2,172 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

Pin, Fixation, Threaded carries 77.2% INJURY-coded reports, 46.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 77.2% corpus 30.3% · above corpus mean (+46.9 pp)
  • MALF 21.6% corpus 64.8% · below corpus mean (-43.2 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 42% of coded problems · Lead manufacturer STRYKER GMBH accounts for 50% of manufacturer-tagged reports · Top event location I is 63% of location-tagged rows .

Pin, Fixation, Threaded in the event-volume neighbourhood

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

reports

What this shows Pin, Fixation, Threaded carries 2,172 MAUDE reports, ranked #476 of 1000.

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

Event Types

Injury 1,676 (77.2%)
Malfunction 469 (21.6%)
Other 19 (0.9%)
6 (0.3%)
Death 2 (0.1%)

Patient Outcomes

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

Required Intervention 1,035 (40.8%)
Other 424 (16.7%)
397 (15.7%)
R 293 (11.6%)
Hospitalization 291 (11.5%)
H 36 (1.4%)
O 32 (1.3%)
Disability 22 (0.9%)
S 3 (0.1%)
Death 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 929
Break 432
Fracture 138
Insufficient Device Problem Information 101
Mechanical Problem 91
Patient Device Interaction Problem 73
Detachment Of Device Component 55
Explanted 46
Migration 42
Replace 36
Device, or device fragments remain in patient 35
Material Fragmentation 27
Implant, removal of 26
Appropriate Device Problem Term/Code Not Available 25
Component(s), broken 24
Device Markings/Labelling Problem 24
Difficult to Remove 24
Device remains implanted 23
Material Deformation 22
Device Dislodged or Dislocated 20

Yearly Trend

92
1992: 2
93
1993: 2
94
1994: 3
95
1995: 1
96
1996: 2
97
1997: 6
98
1998: 3
99
1999: 8
00
2000: 15
01
2001: 13
02
2002: 8
03
2003: 15
04
2004: 16
05
2005: 21
06
2006: 29
07
2007: 25
08
2008: 26
09
2009: 29
10
2010: 29
11
2011: 55
12
2012: 75
13
2013: 69
14
2014: 26
15
2015: 70
16
2016: 46
17
2017: 43
18
2018: 94
19
2019: 575
20
2020: 402
21
2021: 168
22
2022: 121
23
2023: 72
24
2024: 65
25
2025: 29
26
2026: 9

Reports fell to 29 in 2025, down from an average of 69 in the two years before.

Related Entities for Pin, Fixation, Threaded

Event Locations

I 1,365 (62.8%)
671 (30.9%)
HOSPITAL 106 (4.9%)
OTHER 11 (0.5%)
AMBULATORY SURGICAL FACILITY 6 (0.3%)
NO INFORMATION 6 (0.3%)
HOME 2 (0.1%)
INVALID DATA 2 (0.1%)
OUTPATIENT TREATMENT FACILITY 2 (0.1%)
UNKNOWN 1 (0.0%)

Compare STRYKER GMBH vs SMITH & NEPHEW, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Pin, Fixation, Threaded: 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 (2,172 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Pin, Fixation, Threaded 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 Pin, Fixation, Threaded; 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.