2026 data FDA MAUDE openFDA FDA Class II

Pin, Fixation, Smooth

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, Smooth LIGHT-BOOK · MAUDE

#420 of 1000 · 2,868 reports · 1991–2026

  • BOOK 2,868 reports
  • RANK #420 of 1000
  • DEATH 1 death-typed
  • INJ 1,473 injury-typed
  • MALF 1,289 malfunction
  • SPAN 1991–2026
  • PEAK 2024: 297
  • PHOTO Lithotriptor

Nearest event-volume peer: Lithotriptor, Biliary Mechanical (7 report gap)

Pin, Fixation, Smooth sits #420 of 1000 among tracked device types with 2,868 MAUDE reports spanning 1991–2026. 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, Smooth carries 51.4% INJURY-coded reports, 21.1pp 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 51.4% corpus 30.3% · above corpus mean (+21.1 pp)
  • MALF 44.9% corpus 64.8% · below corpus mean (-19.9 pp)

Lead product-problem code Break is 29% of coded problems · Lead manufacturer STRYKER GMBH accounts for 32% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Pin, Fixation, Smooth in the event-volume neighbourhood

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

reports

What this shows Pin, Fixation, Smooth carries 2,868 MAUDE reports, ranked #420 of 1000.

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

Event Types

Injury 1,473 (51.4%)
Malfunction 1,289 (44.9%)
Other 74 (2.6%)
31 (1.1%)
Death 1 (0.0%)

Patient Outcomes

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

Required Intervention 1,020 (34.2%)
Other 910 (30.5%)
850 (28.5%)
R 94 (3.2%)
Hospitalization 73 (2.4%)
S 16 (0.5%)
O 8 (0.3%)
Disability 6 (0.2%)
H 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Death 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Break 741
Adverse Event Without Identified Device or Use Problem 569
Fracture 166
Device Operates Differently Than Expected 151
Replace 100
Explanted 95
Insufficient Device Problem Information 78
Loose 72
Detachment of Device or Device Component 64
Device, or device fragments remain in patient 60
Mechanical Jam 60
Component(s), broken 58
Migration or Expulsion of Device 52
Bent 47
Detachment Of Device Component 45
Appropriate Device Problem Term/Code Not Available 44
Device Slipped 40
Unknown (for use when the device problem is not known) 40
Difficult to Remove 37
Difficult to Insert 32

Yearly Trend

91
1991: 1
92
1992: 2
93
1993: 1
94
1994: 4
95
1995: 8
96
1996: 29
97
1997: 31
98
1998: 56
99
1999: 65
00
2000: 33
01
2001: 18
02
2002: 31
03
2003: 21
04
2004: 28
05
2005: 38
06
2006: 60
07
2007: 46
08
2008: 38
09
2009: 36
10
2010: 33
11
2011: 164
12
2012: 129
13
2013: 187
14
2014: 149
15
2015: 121
16
2016: 128
17
2017: 82
18
2018: 138
19
2019: 222
20
2020: 210
21
2021: 148
22
2022: 96
23
2023: 153
24
2024: 297
25
2025: 39
26
2026: 26

Reports fell to 39 in 2025, down from an average of 225 in the two years before.

Related Entities for Pin, Fixation, Smooth

Event Locations

1,609 (56.1%)
I 913 (31.8%)
HOSPITAL 234 (8.2%)
AMBULATORY SURGICAL FACILITY 25 (0.9%)
INVALID DATA 25 (0.9%)
HOME 20 (0.7%)
NO INFORMATION 17 (0.6%)
UNKNOWN 11 (0.4%)
OTHER 9 (0.3%)
NOT APPLICABLE 2 (0.1%)
OUTPATIENT TREATMENT FACILITY 2 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare STRYKER GMBH vs ARTHREX, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Pin, Fixation, Smooth: 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 (2,868 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

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