2026 data FDA MAUDE openFDA FDA Class II

Nail, Fixation, Bone

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 Nail, Fixation, Bone LIGHT-BOOK · MAUDE

#260 of 1000 · 7,230 reports · 1992–2026

  • BOOK 7,230 reports
  • RANK #260 of 1000
  • DEATH 11 death-typed
  • INJ 4,877 injury-typed
  • MALF 2,313 malfunction
  • SPAN 1992–2026
  • PEAK 2020: 643
  • PHOTO Stent, Iliac

Nearest event-volume peer: Stent, Iliac (12 report gap)

Nail, Fixation, Bone sits #260 of 1000 among tracked device types with 7,230 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

Nail, Fixation, Bone carries 67.5% INJURY-coded reports, 37.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 67.5% corpus 30.3% · above corpus mean (+37.2 pp)
  • MALF 32.0% corpus 64.8% · below corpus mean (-32.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 29% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 31% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Nail, Fixation, Bone in the event-volume neighbourhood

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

reports

What this shows Nail, Fixation, Bone carries 7,230 MAUDE reports, ranked #260 of 1000.

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

Event Types

Injury 4,877 (67.5%)
Malfunction 2,313 (32.0%)
18 (0.2%)
Death 11 (0.2%)
Other 11 (0.2%)

Patient Outcomes

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

Required Intervention 3,428 (41.4%)
2,297 (27.7%)
Hospitalization 947 (11.4%)
R 868 (10.5%)
Other 525 (6.3%)
O 95 (1.1%)
H 90 (1.1%)
Death 11 (0.1%)
S 7 (0.1%)
Disability 6 (0.1%)
Congenital Anomaly 2 (0.0%)
Life Threatening 2 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 2,093
Break 1,510
Device-Device Incompatibility 983
Fracture 456
Explanted 439
Insufficient Device Problem Information 416
Replace 200
Migration or Expulsion of Device 167
Migration 145
Device Operates Differently Than Expected 135
Material Deformation 115
Failure to Align 85
Appropriate Device Problem Term/Code Not Available 80
Detachment of Device or Device Component 72
Difficult to Remove 70
Manufacturing, Packaging or Shipping Problem 70
Material Twisted/Bent 64
Fitting Problem 60
Device Dislodged or Dislocated 56
Device Slipped 56

Yearly Trend

92
1992: 3
93
1993: 9
94
1994: 10
95
1995: 11
96
1996: 5
97
1997: 16
98
1998: 36
99
1999: 27
00
2000: 15
01
2001: 22
02
2002: 35
03
2003: 41
04
2004: 34
05
2005: 50
06
2006: 75
07
2007: 161
08
2008: 169
09
2009: 160
10
2010: 70
11
2011: 104
12
2012: 195
13
2013: 284
14
2014: 388
15
2015: 316
16
2016: 506
17
2017: 287
18
2018: 320
19
2019: 490
20
2020: 643
21
2021: 630
22
2022: 589
23
2023: 358
24
2024: 466
25
2025: 505
26
2026: 200

Reports in 2025 (505) held close to the prior two-year average of 412.

Related Entities for Nail, Fixation, Bone

Event Locations

4,044 (55.9%)
I 2,895 (40.0%)
HOSPITAL 249 (3.4%)
HOME 12 (0.2%)
OTHER 8 (0.1%)
INVALID DATA 7 (0.1%)
UNKNOWN 7 (0.1%)
NO INFORMATION 5 (0.1%)
NOT APPLICABLE 2 (0.0%)
NURSING HOME 1 (0.0%)

Compare SYNTHES GMBH vs SMITH & NEPHEW, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Nail, Fixation, Bone: 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 (7,230 here).

Similar death-typed counts

Nearest other device types by death-typed report count (11 here), distinct from the volume row.

Disclaimer: MAUDE figures for Nail, Fixation, Bone 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 Nail, Fixation, Bone; 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.