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2026 data FDA MAUDE openFDA FDA Class I

Dispenser, Cement

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §888.4200 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Dispenser, Cement LIGHT-BOOK · MAUDE

#926 of 1000 · 456 reports · 1995–2026

  • BOOK 456 reports
  • RANK #926 of 1000
  • DEATH 5 death-typed
  • INJ 90 injury-typed
  • MALF 349 malfunction
  • SPAN 1995–2026
  • PEAK 2025: 93
  • PHOTO Orthosis, Limb Brace

Nearest event-volume peer: Orthosis, Limb Brace (0 report gap)

Dispenser, Cement sits #926 of 1000 among tracked device types with 456 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 →

Malfunction reports run above the device-type norm

Dispenser, Cement carries 76.5% MALFUNCTION-coded reports, 11.7pp 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 19.7% corpus 30.3% · below corpus mean (-10.6 pp)
  • MALF 76.5% corpus 64.8% · above corpus mean (+11.7 pp)

Lead product-problem code Break is 27% of coded problems · Lead manufacturer DEPUY SPINE INC accounts for 25% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

Dispenser, Cement in the event-volume neighbourhood

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

reports

What this shows Dispenser, Cement carries 456 MAUDE reports, ranked #926 of 1000.

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

Event Types

Malfunction 349 (76.5%)
Injury 90 (19.7%)
Other 10 (2.2%)
Death 5 (1.1%)
2 (0.4%)

Patient Outcomes

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

306 (66.5%)
Required Intervention 59 (12.8%)
Other 58 (12.6%)
Hospitalization 21 (4.6%)
Death 6 (1.3%)
R 4 (0.9%)
Disability 3 (0.7%)
L 1 (0.2%)
O 1 (0.2%)
S 1 (0.2%)

Top Product Problems

Break 117
Leak/Splash 63
Mechanical Jam 55
Adverse Event Without Identified Device or Use Problem 31
Mechanical Problem 26
Fracture 23
Mechanics Altered 18
Appropriate Device Problem Term/Code Not Available 12
Failure to Eject 11
Unknown (for use when the device problem is not known) 11
Chemical Problem 9
Contamination /Decontamination Problem 9
Device, or device fragments remain in patient 9
Device-Device Incompatibility 9
Use of Device Problem 9
Device Contaminated During Manufacture or Shipping 6
Difficult to Remove 6
Other (for use when an appropriate device code cannot be identified) 6
Crack 5
Defective Device 5

Yearly Trend

95
1995: 1
96
1996: 8
97
1997: 12
98
1998: 8
99
1999: 3
00
2000: 3
01
2001: 8
02
2002: 8
03
2003: 6
04
2004: 3
05
2005: 2
06
2006: 5
07
2007: 9
08
2008: 4
09
2009: 3
10
2010: 29
11
2011: 10
12
2012: 3
13
2013: 12
14
2014: 12
15
2015: 6
16
2016: 5
17
2017: 14
18
2018: 15
19
2019: 30
20
2020: 23
21
2021: 30
22
2022: 26
23
2023: 30
24
2024: 19
25
2025: 93
26
2026: 16

Reports rose to 93 in 2025, up from an average of 25 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Dispenser, Cement

Top Manufacturers

DEPUY SPINE INC 39
MEDTRONIC SOFAMOR DANEK USA, INC. 27
SYNTHES GMBH 25
ZIMMER, INC. 25
MEDTRONIC SOFAMOR DANEK USA, INC 20
DEPUY ORTHOPAEDICS INC US 17

Event Locations

309 (67.8%)
I 98 (21.5%)
HOSPITAL 40 (8.8%)
INVALID DATA 5 (1.1%)
NOT APPLICABLE 2 (0.4%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
NO INFORMATION 1 (0.2%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Dispenser, Cement: 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 (456 here).

Orthosis, Limb Brace 456 Cable, Electrode 459 Tray, Surgical 452 Blood Grouping Reagent 451

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Anesthesia Conduction Kit 5 Antigens, All Groups, Streptococcus Spp. 5 Apparatus, Exhaust, Surgical 5 Bit, Drill 5

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Dispenser, Cement 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 Dispenser, Cement; 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.