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2026 data FDA MAUDE openFDA

Staple, 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.

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FDA MAUDE casebook

openFDA event book Staple, Fixation, Bone LIGHT-BOOK · MAUDE

#441 of 1000 · 2,423 reports · 1994–2026

  • BOOK 2,423 reports
  • RANK #441 of 1000
  • DEATH 0 death-typed
  • INJ 1,155 injury-typed
  • MALF 1,257 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 318
  • PHOTO Mattress

Nearest event-volume peer: Mattress, Air Flotation, Alternating Pressure (6 report gap)

Staple, Fixation, Bone sits #441 of 1000 among tracked device types with 2,423 MAUDE reports spanning 1994–2026. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 47.7% corpus 30.4% · above corpus mean (+17.2 pp)
  • MALF 51.9% corpus 64.5% · below corpus mean (-12.6 pp)

Lead product-problem code Break is 34% of coded problems · Lead manufacturer DEPUY MITEK LLC US accounts for 25% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .

Staple, Fixation, Bone in the event-volume neighbourhood

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

reports

What this shows Staple, Fixation, Bone carries 2,423 MAUDE reports, ranked #441 of 1000.

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

Event Types

Malfunction 1,257 (51.9%)
Injury 1,155 (47.7%)
Other 8 (0.3%)
3 (0.1%)

Patient Outcomes

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

1,180 (46.5%)
Required Intervention 741 (29.2%)
Other 400 (15.8%)
R 93 (3.7%)
Hospitalization 69 (2.7%)
O 35 (1.4%)
H 10 (0.4%)
S 5 (0.2%)
Disability 2 (0.1%)
Death 1 (0.0%)

Top Product Problems

Break 645
Adverse Event Without Identified Device or Use Problem 532
Detachment of Device or Device Component 146
Fracture 105
Migration 47
Device-Device Incompatibility 38
Material Frayed 37
Migration or Expulsion of Device 37
Device Dislodged or Dislocated 36
Physical Resistance/Sticking 34
Insufficient Information 32
Appropriate Term/Code Not Available 31
Loosening of Implant Not Related to Bone-Ingrowth 31
Manufacturing, Packaging or Shipping Problem 30
Difficult to Advance 25
Crack 23
Material Split, Cut or Torn 23
Material Deformation 21
Material Separation 18
Patient Device Interaction Problem 18

Yearly Trend

94
1994: 1
96
1996: 3
97
1997: 16
98
1998: 22
99
1999: 14
00
2000: 7
01
2001: 7
02
2002: 6
03
2003: 3
04
2004: 6
05
2005: 6
07
2007: 3
08
2008: 14
09
2009: 10
10
2010: 35
11
2011: 62
12
2012: 34
13
2013: 27
14
2014: 49
15
2015: 48
16
2016: 76
17
2017: 116
18
2018: 239
19
2019: 242
20
2020: 234
21
2021: 210
22
2022: 202
23
2023: 175
24
2024: 206
25
2025: 318
26
2026: 32

Related Entities for Staple, Fixation, Bone

Top Manufacturers

DEPUY MITEK LLC US 429
SMITH & NEPHEW, INC. 344
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 242
STRYKER GMBH 209
SYNTHES GMBH 160
DEPUY MITEK 121
ZIMMER BIOMET, INC. 111
ARTHREX, INC. 85

Event Locations

1,177 (48.6%)
I 1,040 (42.9%)
HOSPITAL 180 (7.4%)
NO INFORMATION 11 (0.5%)
AMBULATORY SURGICAL FACILITY 4 (0.2%)
INVALID DATA 4 (0.2%)
HOME 3 (0.1%)
OTHER 2 (0.1%)
UNKNOWN 2 (0.1%)

Compare DEPUY MITEK LLC US vs SMITH & NEPHEW, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Staple, Fixation, Bone, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (2,423 here).

Mattress 2,417 System, Imaging, Pulsed Doppler, Ultrasonic 2,413 Suture, Absorbable, Natural 2,436 Stylet For Catheter, Gastro-Urology 2,398

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 Staple, 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 Staple, 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.