2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §872.4760 (Dental panel).

FDA MAUDE casebook

openFDA event book Plate, Bone MID-BOOK · MAUDE

#214 of 1000 · 10,393 reports · 1992–2026

  • BOOK 10,393 reports
  • RANK #214 of 1000
  • DEATH 21 death-typed
  • INJ 5,207 injury-typed
  • MALF 5,044 malfunction
  • SPAN 1992–2026
  • PEAK 2026: 1,038
  • PHOTO System

Nearest event-volume peer: System, Test, Automated Blood Grouping And Antibody (8 report gap)

Plate, Bone sits #214 of 1000 among tracked device types with 10,393 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

Plate, Bone carries 50.1% INJURY-coded reports, 19.8pp 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 (-1.3 pp)
  • INJ 50.1% corpus 30.3% · above corpus mean (+19.8 pp)
  • MALF 48.5% corpus 64.8% · below corpus mean (-16.3 pp)

Lead product-problem code Break is 37% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 40% of manufacturer-tagged reports · Top event location is 65% 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 10,393 MAUDE reports, ranked #214 of 1000.

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

Event Types

Injury 5,207 (50.1%)
Malfunction 5,044 (48.5%)
Other 105 (1.0%)
Death 21 (0.2%)
16 (0.2%)

Patient Outcomes

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

4,989 (44.8%)
Required Intervention 3,362 (30.2%)
Other 954 (8.6%)
Hospitalization 897 (8.1%)
R 715 (6.4%)
O 67 (0.6%)
H 39 (0.4%)
Disability 38 (0.3%)
S 36 (0.3%)
Death 22 (0.2%)
Life Threatening 3 (0.0%)
L 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Break 3,704
Adverse Event Without Identified Device or Use Problem 1,873
Fracture 874
Material Deformation 719
Insufficient Device Problem Information 546
Device Slipped 267
Detachment Of Device Component 241
Device-Device Incompatibility 217
Material Twisted/Bent 189
Manufacturing, Packaging or Shipping Problem 161
Device Operates Differently Than Expected 157
Explanted 133
Migration or Expulsion of Device 123
Difficult to Insert 119
Migration 117
Appropriate Device Problem Term/Code Not Available 111
Device Dislodged or Dislocated 108
Material Fragmentation 106
No Apparent Adverse Event 97
Unintended Movement 86

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: 1,038

Reports rose to 1,017 in 2025, up from an average of 596 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Plate, Bone

Event Locations

6,753 (65.0%)
I 3,344 (32.2%)
HOSPITAL 245 (2.4%)
NO INFORMATION 25 (0.2%)
OTHER 6 (0.1%)
UNKNOWN 6 (0.1%)
HOME 5 (0.0%)
INVALID DATA 5 (0.0%)
OUTPATIENT TREATMENT FACILITY 4 (0.0%)

Compare SYNTHES GMBH vs BIOMET MICROFIXATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Plate, 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 (10,393 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.