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2026 data FDA MAUDE openFDA

Plate, 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 Plate, Fixation, Bone MID-BOOK · MAUDE

#88 of 1000 · 37,887 reports · 1992–2026

  • BOOK 37,887 reports
  • RANK #88 of 1000
  • DEATH 74 death-typed
  • INJ 28,684 injury-typed
  • MALF 8,657 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 3,358
  • PHOTO Insulin Pump Secondar…

Nearest event-volume peer: Insulin Pump Secondary Display (43 report gap)

Plate, Fixation, Bone sits #88 of 1000 among tracked device types with 37,887 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 →

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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 75.7% corpus 30.4% · above corpus mean (+45.3 pp)
  • MALF 22.8% corpus 64.5% · below corpus mean (-41.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 44% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 19% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Plate, Fixation, Bone in the event-volume neighbourhood

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

reports

What this shows Plate, Fixation, Bone carries 37,887 MAUDE reports, ranked #88 of 1000.

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

Event Types

Injury 28,684 (75.7%)
Malfunction 8,657 (22.8%)
Other 310 (0.8%)
162 (0.4%)
Death 74 (0.2%)

Patient Outcomes

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

Required Intervention 21,329 (50.9%)
7,665 (18.3%)
Other 5,252 (12.5%)
Hospitalization 3,453 (8.2%)
R 3,106 (7.4%)
H 492 (1.2%)
O 306 (0.7%)
S 101 (0.2%)
Death 78 (0.2%)
Disability 55 (0.1%)
L 28 (0.1%)
Life Threatening 28 (0.1%)
Congenital Anomaly 10 (0.0%)
D 6 (0.0%)
Invalid Data 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 9,864
Break 4,420
Fracture 1,943
Device-Device Incompatibility 956
Migration 822
Insufficient Information 638
Migration or Expulsion of Device 470
Appropriate Term/Code Not Available 399
Material Twisted/Bent 309
Device Dislodged or Dislocated 258
Patient Device Interaction Problem 252
Device Operates Differently Than Expected 234
Device Slipped 228
Loosening of Implant Not Related to Bone-Ingrowth 228
No Apparent Adverse Event 221
Material Deformation 211
Patient-Device Incompatibility 210
Positioning Failure 203
Use of Device Problem 182
Unintended Movement 169

Yearly Trend

92
1992: 3
93
1993: 12
94
1994: 34
95
1995: 25
96
1996: 46
97
1997: 130
98
1998: 164
99
1999: 148
00
2000: 112
01
2001: 115
02
2002: 169
03
2003: 146
04
2004: 201
05
2005: 191
06
2006: 277
07
2007: 339
08
2008: 311
09
2009: 434
10
2010: 490
11
2011: 773
12
2012: 1,660
13
2013: 2,642
14
2014: 2,413
15
2015: 3,095
16
2016: 2,276
17
2017: 2,220
18
2018: 2,663
19
2019: 3,358
20
2020: 2,790
21
2021: 2,442
22
2022: 1,700
23
2023: 2,049
24
2024: 1,849
25
2025: 2,331
26
2026: 279

Related Entities for Plate, Fixation, Bone

Top Manufacturers

SYNTHES GMBH 4,419
SYNTHES USA 4,020
OBERDORF SYNTHES PRODUKTIONS GMBH 2,832
STRYKER GMBH 2,830
BIOMET MICROFIXATION 2,271
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2,205
SYNTHES (USA) 1,919
ZIMMER BIOMET, INC. 1,178
SMITH & NEPHEW, INC. 1,084

Event Locations

20,098 (53.0%)
I 16,209 (42.8%)
HOSPITAL 1,196 (3.2%)
NO INFORMATION 117 (0.3%)
HOME 74 (0.2%)
INVALID DATA 46 (0.1%)
UNKNOWN 46 (0.1%)
OTHER 43 (0.1%)
AMBULATORY SURGICAL FACILITY 26 (0.1%)
OUTPATIENT TREATMENT FACILITY 15 (0.0%)
NOT APPLICABLE 6 (0.0%)
NURSING HOME 5 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (0.0%)
AMBULATORY SURGICAL CENTER 1 (0.0%)
PUBLIC VENUE 1 (0.0%)

Compare SYNTHES GMBH vs SYNTHES USA →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Plate, 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 (37,887 here).

Insulin Pump Secondary Display 37,844 Temporary Non-Roller Type Left Heart Suppor… 38,070 Introducer, Catheter 38,107 Filter, Intravascular, Cardiovascular 38,166

Similar death-typed counts

Nearest other device types by death-typed report count (74 here), distinct from the volume row.

Vehicle, Motorized 3-Wheeled 74 Lift, Patient, Ac-Powered 75 Negative Pressure Wound Therapy Powered Suc… 75 Transmitters And Receivers 73

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Plate, 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 Plate, 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.