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 Class II (moderate risk, special controls required), regulated under 21 CFR §888.3010 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Cerclage, Fixation LIGHT-BOOK · MAUDE
#442 of 1000 · 2,614 reports · 1995–2026
- BOOK 2,614 reports
- RANK #442 of 1000
- DEATH 30 death-typed
- INJ 1,258 injury-typed
- MALF 1,288 malfunction
- SPAN 1995–2026
- PEAK 2013: 321
- PHOTO Prosthesis
Nearest event-volume peer: Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal (7 report gap)
Cerclage, Fixation sits #442 of 1000 among tracked device types with 2,614 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 →
Injury-coded reports run above the device-type norm
Cerclage, Fixation carries 48.1% INJURY-coded reports, 17.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
- INJ 48.1% corpus 30.3% · above corpus mean (+17.8 pp)
- MALF 49.3% corpus 64.8% · below corpus mean (-15.6 pp)
Lead product-problem code Break is 24% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 40% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .
Cerclage, Fixation in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Handpiece
Handpiece, Contra- And Right-Angle Attachment, Dental
2,629 reports
- Device
Device, Anti-Snoring
2,628 reports
- Prosthesis
Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
2,621 reports
- Cerclage (this)
Cerclage, Fixation
2,614 reports
- Catheter
Catheter, Conduction, Anesthetic
2,605 reports
- Catheter
Catheter, Urethral
2,601 reports
What this shows Cerclage, Fixation carries 2,614 MAUDE reports, ranked #442 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (88) held close to the prior two-year average of 107.
Related Entities for Cerclage, Fixation
Top Manufacturers
Event Locations
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 Cerclage, Fixation: 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 (2,614 here).
Similar death-typed counts
Nearest other device types by death-typed report count (30 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
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.