2026 data FDA MAUDE openFDA

Plate, 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 MAUDE casebook

openFDA event book Plate, Bone LIGHT-BOOK · MAUDE

#219 of 1000 · 9,475 reports · 1992–2026

  • BOOK 9,475 reports
  • RANK #219 of 1000
  • DEATH 21 death-typed
  • INJ 5,128 injury-typed
  • MALF 4,205 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 1,017
  • PHOTO Ring, Annuloplasty

Nearest event-volume peer: Ring, Annuloplasty (4 report gap)

Plate, Bone sits #219 of 1000 among tracked device types with 9,475 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 54.1% corpus 30.4% · above corpus mean (+23.7 pp)
  • MALF 44.4% corpus 64.5% · below corpus mean (-20.1 pp)

Lead product-problem code Break is 35% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 33% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

Plate, Bone in the event-volume neighbourhood

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

reports

What this shows Plate, Bone carries 9,475 MAUDE reports, ranked #219 of 1000.

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

Event Types

Injury 5,128 (54.1%)
Malfunction 4,205 (44.4%)
Other 105 (1.1%)
Death 21 (0.2%)
16 (0.2%)

Patient Outcomes

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

4,271 (41.4%)
Required Intervention 3,323 (32.2%)
Other 912 (8.8%)
Hospitalization 893 (8.7%)
R 712 (6.9%)
O 67 (0.6%)
Disability 38 (0.4%)
H 37 (0.4%)
S 37 (0.4%)
Death 22 (0.2%)
Life Threatening 3 (0.0%)
L 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Break 2,123
Adverse Event Without Identified Device or Use Problem 1,418
Fracture 716
Device-Device Incompatibility 211
Material Twisted/Bent 173
Material Deformation 169
Device Slipped 167
Insufficient Information 138
Manufacturing, Packaging or Shipping Problem 129
Migration 114
No Apparent Adverse Event 95
Migration or Expulsion of Device 76
Device Contaminated During Manufacture or Shipping 73
Unintended Movement 72
Entrapment of Device 69
Material Fragmentation 64
Crack 52
Loosening of Implant Not Related to Bone-Ingrowth 52
Inadequacy of Device Shape and/or Size 51
Device Appears to Trigger Rejection 50

Yearly Trend

92
1992: 2
93
1993: 1
94
1994: 3
96
1996: 3
97
1997: 19
98
1998: 15
99
1999: 8
00
2000: 9
01
2001: 14
02
2002: 6
03
2003: 15
04
2004: 21
05
2005: 13
06
2006: 35
07
2007: 29
08
2008: 24
09
2009: 93
10
2010: 215
11
2011: 241
12
2012: 428
13
2013: 766
14
2014: 616
15
2015: 767
16
2016: 558
17
2017: 568
18
2018: 608
19
2019: 595
20
2020: 680
21
2021: 451
22
2022: 344
23
2023: 495
24
2024: 696
25
2025: 1,017
26
2026: 120

Related Entities for Plate, Bone

Event Locations

5,835 (61.6%)
I 3,344 (35.3%)
HOSPITAL 245 (2.6%)
NO INFORMATION 25 (0.3%)
OTHER 6 (0.1%)
UNKNOWN 6 (0.1%)
HOME 5 (0.1%)
INVALID DATA 5 (0.1%)
OUTPATIENT TREATMENT FACILITY 4 (0.0%)

Compare SYNTHES GMBH vs BIOMET MICROFIXATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Plate, 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 (9,475 here).

Similar death-typed counts

Nearest other device types by death-typed report count (21 here), distinct from the volume row.

Disclaimer: MAUDE figures for Plate, 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, 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.