2026 data FDA MAUDE openFDA

Cerclage, Fixation

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 Cerclage, Fixation LIGHT-BOOK · MAUDE

#431 of 1000 · 2,562 reports · 1995–2026

  • BOOK 2,562 reports
  • RANK #431 of 1000
  • DEATH 30 death-typed
  • INJ 1,249 injury-typed
  • MALF 1,245 malfunction
  • SPAN 1995–2026
  • PEAK 2013: 321
  • PHOTO Intraocular Pressure…

Nearest event-volume peer: Intraocular Pressure Lowering Implant (14 report gap)

Cerclage, Fixation sits #431 of 1000 among tracked device types with 2,562 MAUDE reports spanning 1995–2026. 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 1.2% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 48.8% corpus 30.4% · above corpus mean (+18.3 pp)
  • MALF 48.6% corpus 64.5% · below corpus mean (-15.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 25% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 38% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Cerclage, Fixation in the event-volume neighbourhood

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

reports

What this shows Cerclage, Fixation carries 2,562 MAUDE reports, ranked #431 of 1000.

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

Event Types

Injury 1,249 (48.8%)
Malfunction 1,245 (48.6%)
Death 30 (1.2%)
Other 22 (0.9%)
16 (0.6%)

Patient Outcomes

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

1,223 (42.7%)
Required Intervention 908 (31.7%)
R 247 (8.6%)
Hospitalization 240 (8.4%)
Other 158 (5.5%)
Death 30 (1.0%)
O 27 (0.9%)
H 23 (0.8%)
S 5 (0.2%)
Life Threatening 3 (0.1%)
L 2 (0.1%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 350
Break 336
Mechanical Problem 252
Device Operates Differently Than Expected 130
Fracture 69
Insufficient Information 65
Device-Device Incompatibility 44
Device Slipped 25
Migration 24
Appropriate Term/Code Not Available 17
Material Deformation 17
No Apparent Adverse Event 15
Unintended Movement 15
Mechanical Jam 12
Component Missing 11
Material Frayed 10
Failure To Adhere Or Bond 9
Migration or Expulsion of Device 9
Crack 7
Device Dislodged or Dislocated 7

Yearly Trend

95
1995: 1
96
1996: 5
97
1997: 19
98
1998: 15
99
1999: 17
00
2000: 17
01
2001: 14
02
2002: 30
03
2003: 4
04
2004: 12
05
2005: 9
06
2006: 12
07
2007: 5
08
2008: 25
09
2009: 19
10
2010: 28
11
2011: 30
12
2012: 130
13
2013: 321
14
2014: 223
15
2015: 205
16
2016: 224
17
2017: 138
18
2018: 182
19
2019: 158
20
2020: 125
21
2021: 141
22
2022: 134
23
2023: 98
24
2024: 115
25
2025: 88
26
2026: 18

Related Entities for Cerclage, Fixation

Event Locations

1,439 (56.2%)
I 1,008 (39.3%)
HOSPITAL 85 (3.3%)
UNKNOWN 10 (0.4%)
HOME 5 (0.2%)
INVALID DATA 5 (0.2%)
NO INFORMATION 5 (0.2%)
NOT APPLICABLE 3 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OTHER 1 (0.0%)

Compare SYNTHES GMBH vs WRIGHTS LANE SYNTHES USA PRODUCTS LLC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Cerclage, Fixation, 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 (2,562 here).

Similar death-typed counts

Nearest other device types by death-typed report count (30 here), distinct from the volume row.

Disclaimer: MAUDE figures for Cerclage, Fixation 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 Cerclage, Fixation; 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.