2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §888.3027 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Cement, Bone, Vertebroplasty LIGHT-BOOK · MAUDE

#327 of 1000 · 4,809 reports · 2004–2026

  • BOOK 4,809 reports
  • RANK #327 of 1000
  • DEATH 94 death-typed
  • INJ 1,084 injury-typed
  • MALF 3,598 malfunction
  • SPAN 2004–2026
  • PEAK 2025: 639
  • PHOTO Mesh

Nearest event-volume peer: Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (35 report gap)

Cement, Bone, Vertebroplasty sits #327 of 1000 among tracked device types with 4,809 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 →

Malfunction reports run above the device-type norm

Cement, Bone, Vertebroplasty carries 74.8% MALFUNCTION-coded reports, 10.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.0% corpus 1.5% · near corpus mean (+0.4 pp)
  • INJ 22.5% corpus 30.3% · below corpus mean (-7.8 pp)
  • MALF 74.8% corpus 64.8% · above corpus mean (+10.0 pp)

Lead product-problem code Leak/Splash is 12% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 50% of manufacturer-tagged reports · Top event location is 69% 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 4,809 MAUDE reports, ranked #327 of 1000.

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

Event Types

Malfunction 3,598 (74.8%)
Injury 1,084 (22.5%)
Death 94 (2.0%)
Other 25 (0.5%)
8 (0.2%)

Patient Outcomes

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

3,516 (71.8%)
Required Intervention 612 (12.5%)
Other 366 (7.5%)
R 114 (2.3%)
Death 78 (1.6%)
Hospitalization 77 (1.6%)
Life Threatening 48 (1.0%)
O 33 (0.7%)
Disability 21 (0.4%)
S 18 (0.4%)
L 10 (0.2%)
H 7 (0.1%)

Top Product Problems

Leak/Splash 600
Migration or Expulsion of Device 547
Appropriate Device Problem Term/Code Not Available 404
Adverse Event Without Identified Device or Use Problem 399
Improper Chemical Reaction 395
Coagulation in Device or Device Ingredient 344
Fluid/Blood Leak 305
Inflation Problem 280
Break 243
Material Integrity Problem 224
Failure to Eject 202
Chemical Problem 197
Compatibility Problem 145
No Apparent Adverse Event 113
Migration 106
Insufficient Device Problem Information 102
Device Operates Differently Than Expected 93
Activation, Positioning or Separation Problem 58
Product Quality Problem 55
Device remains implanted 48

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: 378

Reports rose to 639 in 2025, up from an average of 383 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Cement, Bone, Vertebroplasty

Event Locations

3,334 (69.3%)
I 1,270 (26.4%)
HOSPITAL 183 (3.8%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Cement, Bone, Vertebroplasty: 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 (4,809 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.