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2026 data FDA MAUDE openFDA FDA Class II

Filler, Bone Void, Calcium Compound

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 §888.3045 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Filler, Bone Void, Calcium Compound LIGHT-BOOK · MAUDE

#495 of 1000 · 2,056 reports · 1998–2026

  • BOOK 2,056 reports
  • RANK #495 of 1000
  • DEATH 44 death-typed
  • INJ 1,322 injury-typed
  • MALF 467 malfunction
  • SPAN 1998–2026
  • PEAK 2013: 223
  • PHOTO Ligator, Hemorrhoidal

Nearest event-volume peer: Ligator, Hemorrhoidal (2 report gap)

Filler, Bone Void, Calcium Compound sits #495 of 1000 among tracked device types with 2,056 MAUDE reports spanning 1998–2026. 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 sit below the device-type norm

Filler, Bone Void, Calcium Compound carries 22.7% MALFUNCTION-coded reports, 42.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.1% corpus 1.5% · above corpus mean (+0.6 pp)
  • INJ 64.3% corpus 30.3% · above corpus mean (+34.0 pp)
  • MALF 22.7% corpus 64.8% · below corpus mean (-42.1 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 30% of coded problems · Lead manufacturer WRIGHT MEDICAL TECHNOLOGY, INC. accounts for 36% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .

Filler, Bone Void, Calcium Compound in the event-volume neighbourhood

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

reports

What this shows Filler, Bone Void, Calcium Compound carries 2,056 MAUDE reports, ranked #495 of 1000.

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

Event Types

Injury 1,322 (64.3%)
Malfunction 467 (22.7%)
Other 186 (9.0%)
Death 44 (2.1%)
37 (1.8%)

Patient Outcomes

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

Required Intervention 685 (28.3%)
517 (21.4%)
Other 431 (17.8%)
Hospitalization 339 (14.0%)
R 239 (9.9%)
O 67 (2.8%)
Death 45 (1.9%)
S 30 (1.2%)
H 18 (0.7%)
Disability 17 (0.7%)
L 15 (0.6%)
Life Threatening 14 (0.6%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 551
Insufficient Device Problem Information 380
Device Operates Differently Than Expected 111
Break 107
Unknown (for use when the device problem is not known) 106
Migration or Expulsion of Device 75
Device remains implanted 61
Appropriate Device Problem Term/Code Not Available 51
Fracture 46
Use of Device Problem 44
Patient-Device Incompatibility 43
Failure to Osseointegrate 42
Explanted 34
Migration 34
Improper or Incorrect Procedure or Method 30
No Apparent Adverse Event 28
Device Expiration Issue 26
Nonstandard Device 26
Leak/Splash 24
Chemical Problem 23

Yearly Trend

98
1998: 2
00
2000: 7
01
2001: 2
02
2002: 6
03
2003: 1
04
2004: 36
05
2005: 32
06
2006: 28
07
2007: 67
08
2008: 71
09
2009: 81
10
2010: 68
11
2011: 114
12
2012: 149
13
2013: 223
14
2014: 111
15
2015: 125
16
2016: 106
17
2017: 107
18
2018: 86
19
2019: 65
20
2020: 126
21
2021: 101
22
2022: 47
23
2023: 120
24
2024: 68
25
2025: 58
26
2026: 49

Reports fell to 58 in 2025, down from an average of 94 in the two years before.

Related Entities for Filler, Bone Void, Calcium Compound

Top Manufacturers

WRIGHT MEDICAL TECHNOLOGY, INC. 181
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 90
SYNTHES GMBH 87
SYNTHES USA 77
SYNTHES MONUMENT 74

Event Locations

1,210 (58.9%)
I 547 (26.6%)
HOSPITAL 196 (9.5%)
OTHER 48 (2.3%)
NO INFORMATION 19 (0.9%)
AMBULATORY SURGICAL FACILITY 15 (0.7%)
HOME 9 (0.4%)
OUTPATIENT TREATMENT FACILITY 6 (0.3%)
UNKNOWN 6 (0.3%)

Compare WRIGHT MEDICAL TECHNOLOGY, INC. vs WRIGHTS LANE SYNTHES USA PRODUCTS LLC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Filler, Bone Void, Calcium Compound: 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 (2,056 here).

Ligator, Hemorrhoidal 2,058 Continuous Glucose Monitor Retrospective Da… 2,060 Apparatus, Nitric Oxide Delivery 2,049 Prosthesis 2,066

Similar death-typed counts

Nearest other device types by death-typed report count (44 here), distinct from the volume row.

Implant, Endosseous, Root-Form 44 System, Hypothermia, Intravenous, Cooling 44 Bath, Hydro-Massage 43 Filler 45

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

Disclaimer: MAUDE figures for Filler, Bone Void, Calcium Compound 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 Filler, Bone Void, Calcium Compound; 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.