2026 data FDA MAUDE openFDA FDA Class II

Condylar Plate Fixation Implant

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 Condylar Plate Fixation Implant LIGHT-BOOK · MAUDE

#701 of 1000 · 876 reports · 1992–2026

  • BOOK 876 reports
  • RANK #701 of 1000
  • DEATH 2 death-typed
  • INJ 717 injury-typed
  • MALF 152 malfunction
  • SPAN 1992–2026
  • PEAK 2016: 117
  • PHOTO Graft

Nearest event-volume peer: Graft, Vascular, Synthetic/Biologic Composite (2 report gap)

Condylar Plate Fixation Implant sits #701 of 1000 among tracked device types with 876 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

Condylar Plate Fixation Implant carries 81.8% INJURY-coded reports, 51.6pp 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 81.8% corpus 30.3% · above corpus mean (+51.6 pp)
  • MALF 17.4% corpus 64.8% · below corpus mean (-47.5 pp)

Lead product-problem code Break is 37% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 33% of manufacturer-tagged reports · Top event location I is 49% of location-tagged rows .

Condylar Plate Fixation Implant in the event-volume neighbourhood

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

reports

What this shows Condylar Plate Fixation Implant carries 876 MAUDE reports, ranked #701 of 1000.

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

Event Types

Injury 717 (81.8%)
Malfunction 152 (17.4%)
5 (0.6%)
Death 2 (0.2%)

Patient Outcomes

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

Required Intervention 693 (78.5%)
152 (17.2%)
Other 16 (1.8%)
R 8 (0.9%)
Hospitalization 7 (0.8%)
Invalid Data 5 (0.6%)
Death 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Break 326
Adverse Event Without Identified Device or Use Problem 234
Device-Device Incompatibility 98
Unintended Movement 36
Material Twisted/Bent 27
Migration or Expulsion of Device 17
Insufficient Device Problem Information 16
Device Slipped 15
Device Dislodged or Dislocated 14
Bent 11
Failure To Adhere Or Bond 11
Material Deformation 11
Fracture 9
Appropriate Device Problem Term/Code Not Available 8
Corroded 7
Detachment of Device or Device Component 7
Device Operates Differently Than Expected 7
Migration 7
Fitting Problem 6
Loose or Intermittent Connection 6

Yearly Trend

92
1992: 11
93
1993: 7
94
1994: 8
95
1995: 4
97
1997: 1
98
1998: 2
99
1999: 1
04
2004: 1
06
2006: 1
07
2007: 1
08
2008: 1
09
2009: 1
10
2010: 1
11
2011: 2
12
2012: 21
13
2013: 83
14
2014: 55
15
2015: 97
16
2016: 117
17
2017: 46
18
2018: 56
19
2019: 49
20
2020: 56
21
2021: 79
22
2022: 61
23
2023: 29
24
2024: 30
25
2025: 44
26
2026: 11

Reports rose to 44 in 2025, up from an average of 30 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Condylar Plate Fixation Implant

Event Locations

I 432 (49.3%)
407 (46.5%)
HOSPITAL 21 (2.4%)
INVALID DATA 8 (0.9%)
HOME 6 (0.7%)
OTHER 2 (0.2%)

Compare SYNTHES GMBH vs WRIGHTS LANE SYNTHES USA PRODUCTS LLC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Condylar Plate Fixation Implant: 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 (876 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Condylar Plate Fixation Implant 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 Condylar Plate Fixation Implant; 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.