2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Spinal Vertebral Body Replacement Device LIGHT-BOOK · MAUDE

#412 of 1000 · 2,843 reports · 2003–2026

  • BOOK 2,843 reports
  • RANK #412 of 1000
  • DEATH 14 death-typed
  • INJ 1,447 injury-typed
  • MALF 1,352 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 #412 of 1000 among tracked device types with 2,843 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 →

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 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 50.9% corpus 30.4% · above corpus mean (+20.5 pp)
  • MALF 47.6% corpus 64.5% · below corpus mean (-17.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 24% of coded problems · Lead manufacturer MEDTRONIC SOFAMOR DANEK USA, INC accounts for 35% of manufacturer-tagged reports · Top event location is 56% 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

reports

What this shows Spinal Vertebral Body Replacement Device carries 2,843 MAUDE reports, ranked #412 of 1000.

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

Event Types

Injury 1,447 (50.9%)
Malfunction 1,352 (47.6%)
Other 21 (0.7%)
Death 14 (0.5%)
9 (0.3%)

Patient Outcomes

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

1,227 (40.5%)
Required Intervention 1,076 (35.5%)
Other 377 (12.5%)
R 133 (4.4%)
Hospitalization 123 (4.1%)
O 22 (0.7%)
S 21 (0.7%)
Disability 14 (0.5%)
Death 12 (0.4%)
L 10 (0.3%)
Life Threatening 8 (0.3%)
H 5 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 335
Break 201
Migration 134
Mechanical Problem 99
Migration or Expulsion of Device 87
Mechanics Altered 68
Material Deformation 67
No Apparent Adverse Event 42
Fracture 38
Collapse 37
Insufficient Information 36
Device Dislodged or Dislocated 32
Unintended Movement 32
Detachment of Device or Device Component 30
Mechanical Jam 29
Activation Failure 27
Appropriate Term/Code Not Available 22
Material Integrity Problem 21
Device Operates Differently Than Expected 20
Patient Device Interaction Problem 20

Yearly Trend

03
2003: 16
04
2004: 14
05
2005: 39
06
2006: 40
07
2007: 61
08
2008: 76
09
2009: 111
10
2010: 166
11
2011: 121
12
2012: 141
13
2013: 207
14
2014: 216
15
2015: 258
16
2016: 129
17
2017: 141
18
2018: 130
19
2019: 117
20
2020: 157
21
2021: 208
22
2022: 137
23
2023: 71
24
2024: 98
25
2025: 171
26
2026: 18

Related Entities for Spinal Vertebral Body Replacement Device

Event Locations

1,601 (56.3%)
I 911 (32.0%)
HOSPITAL 272 (9.6%)
NO INFORMATION 38 (1.3%)
HOME 10 (0.4%)
OTHER 10 (0.4%)
NURSING HOME 1 (0.0%)

Compare MEDTRONIC SOFAMOR DANEK USA, INC vs DEPUY SYNTHES SPINE →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Spinal Vertebral Body Replacement Device, 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 (2,843 here).

Similar death-typed counts

Nearest other device types by death-typed report count (14 here), distinct from the volume row.

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.