Spinal Vertebral Body Replacement Device
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 §888.3060 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Spinal Vertebral Body Replacement Device LIGHT-BOOK · MAUDE
#415 of 1000 · 2,930 reports · 2003–2026
- BOOK 2,930 reports
- RANK #415 of 1000
- DEATH 14 death-typed
- INJ 1,458 injury-typed
- MALF 1,428 malfunction
- SPAN 2003–2026
- PEAK 2015: 258
- PHOTO Aid
Nearest event-volume peer: Aid, Surgical, Viscoelastic (2 report gap)
Spinal Vertebral Body Replacement Device sits #415 of 1000 among tracked device types with 2,930 MAUDE reports spanning 2003–2026. 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
Spinal Vertebral Body Replacement Device carries 49.8% INJURY-coded reports, 19.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
- INJ 49.8% corpus 30.3% · above corpus mean (+19.5 pp)
- MALF 48.7% corpus 64.8% · below corpus mean (-16.1 pp)
Lead product-problem code Break is 24% of coded problems · Lead manufacturer MEDTRONIC SOFAMOR DANEK USA, INC accounts for 33% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .
Spinal Vertebral Body Replacement Device in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Assay
Assay, Glycosylated Hemoglobin
2,943 reports
- Syringe
Syringe, Antistick
2,941 reports
- Spinal Verteb… (this)
Spinal Vertebral Body Replacement Device
2,930 reports
- Aid
Aid, Surgical, Viscoelastic
2,928 reports
- Implanted Sub…
Implanted Subcortical Electrical Stimulator (Motor Disorders)
2,909 reports
- Prosthesis
Prosthesis, Spinous Process Spacer/Plate
2,908 reports
What this shows Spinal Vertebral Body Replacement Device carries 2,930 MAUDE reports, ranked #415 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 rose to 170 in 2025, up from an average of 86 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Spinal Vertebral Body Replacement Device
Top Manufacturers
Event Locations
Compare MEDTRONIC SOFAMOR DANEK USA, INC vs DEPUY SYNTHES SPINE →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Spinal Vertebral Body Replacement Device: 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 (2,930 here).
Similar death-typed counts
Nearest other device types by death-typed report count (14 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Spinal Vertebral Body Replacement Device 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 Spinal Vertebral Body Replacement Device; 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.