2026 data FDA MAUDE openFDA

Cement, Bone, Vertebroplasty

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 Cement, Bone, Vertebroplasty LIGHT-BOOK · MAUDE

#330 of 1000 · 4,555 reports · 2004–2026

  • BOOK 4,555 reports
  • RANK #330 of 1000
  • DEATH 94 death-typed
  • INJ 1,061 injury-typed
  • MALF 3,367 malfunction
  • SPAN 2004–2026
  • PEAK 2025: 639
  • PHOTO System

Nearest event-volume peer: System, Nuclear Magnetic Resonance Imaging (34 report gap)

Cement, Bone, Vertebroplasty sits #330 of 1000 among tracked device types with 4,555 MAUDE reports spanning 2004–2026. 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 2.1% corpus 1.5% · above corpus mean (+0.5 pp)
  • INJ 23.3% corpus 30.4% · below corpus mean (-7.1 pp)
  • MALF 73.9% corpus 64.5% · above corpus mean (+9.4 pp)

Lead product-problem code Leak/Splash is 11% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 49% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

Cement, Bone, Vertebroplasty in the event-volume neighbourhood

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

reports

What this shows Cement, Bone, Vertebroplasty carries 4,555 MAUDE reports, ranked #330 of 1000.

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

Event Types

Malfunction 3,367 (73.9%)
Injury 1,061 (23.3%)
Death 94 (2.1%)
Other 25 (0.5%)
8 (0.2%)

Patient Outcomes

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

3,353 (71.1%)
Required Intervention 603 (12.8%)
Other 358 (7.6%)
R 113 (2.4%)
Death 78 (1.7%)
Hospitalization 75 (1.6%)
Life Threatening 48 (1.0%)
O 32 (0.7%)
Disability 21 (0.4%)
S 18 (0.4%)
L 10 (0.2%)
H 7 (0.1%)

Top Product Problems

Leak/Splash 380
Improper Chemical Reaction 334
Adverse Event Without Identified Device or Use Problem 325
Coagulation in Device or Device Ingredient 296
Migration or Expulsion of Device 260
Fluid/Blood Leak 256
Inflation Problem 238
Chemical Problem 189
Failure to Eject 186
Material Integrity Problem 184
Break 138
Compatibility Problem 122
Appropriate Term/Code Not Available 108
Migration 103
Device Operates Differently Than Expected 49
Activation, Positioning or Separation Problem 48
Product Quality Problem 42
Fracture 36
Activation Failure 25
No Apparent Adverse Event 23

Yearly Trend

04
2004: 7
05
2005: 16
06
2006: 44
07
2007: 21
08
2008: 39
09
2009: 70
10
2010: 396
11
2011: 98
12
2012: 89
13
2013: 242
14
2014: 231
15
2015: 204
16
2016: 182
17
2017: 191
18
2018: 144
19
2019: 227
20
2020: 212
21
2021: 344
22
2022: 270
23
2023: 311
24
2024: 454
25
2025: 639
26
2026: 124

Related Entities for Cement, Bone, Vertebroplasty

Event Locations

3,080 (67.6%)
I 1,270 (27.9%)
HOSPITAL 183 (4.0%)
NO INFORMATION 17 (0.4%)
HOME 2 (0.0%)
OTHER 2 (0.0%)
NURSING HOME 1 (0.0%)

Compare SYNTHES GMBH vs MEDTRONIC SOFAMOR DANEK →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Cement, Bone, Vertebroplasty, 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 (4,555 here).

Similar death-typed counts

Nearest other device types by death-typed report count (94 here), distinct from the volume row.

Disclaimer: MAUDE figures for Cement, Bone, Vertebroplasty 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 Cement, Bone, Vertebroplasty; 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.