2026 data FDA MAUDE openFDA

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

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 Filler MID-BOOK · MAUDE

#183 of 1000 · 13,013 reports · 2003–2026

  • BOOK 13,013 reports
  • RANK #183 of 1000
  • DEATH 45 death-typed
  • INJ 12,834 injury-typed
  • MALF 74 malfunction
  • SPAN 2003–2026
  • PEAK 2013: 3,497
  • PHOTO Bone Cement

Nearest event-volume peer: Bone Cement (26 report gap)

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction sits #183 of 1000 among tracked device types with 13,013 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 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 98.6% corpus 30.4% · above corpus mean (+68.2 pp)
  • MALF 0.6% corpus 64.5% · below corpus mean (-63.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 96% of coded problems · Lead manufacturer MEDTRONIC SOFAMOR DANEK USA, INC accounts for 87% of manufacturer-tagged reports · Top event location I is 50% of location-tagged rows .

Filler in the event-volume neighbourhood

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

reports

What this shows Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction carries 13,013 MAUDE reports, ranked #183 of 1000.

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

Event Types

Injury 12,834 (98.6%)
Malfunction 74 (0.6%)
Death 45 (0.3%)
44 (0.3%)
Other 16 (0.1%)

Patient Outcomes

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

Other 8,305 (58.3%)
Required Intervention 3,797 (26.7%)
R 902 (6.3%)
476 (3.3%)
Hospitalization 300 (2.1%)
S 200 (1.4%)
O 72 (0.5%)
Disability 52 (0.4%)
L 47 (0.3%)
Death 45 (0.3%)
Life Threatening 36 (0.3%)
H 5 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 2,605
Off-Label Use 53
Osseointegration Problem 19
Insufficient Information 7
Appropriate Term/Code Not Available 5
Migration or Expulsion of Device 5
Break 4
Microbial Contamination of Device 3
Device Operates Differently Than Expected 2
Failure to Osseointegrate 2
Leak/Splash 2
Loosening of Implant Not Related to Bone-Ingrowth 2
Nonstandard Device 2
Collapse 1
Defective Device 1
Device Contamination with Chemical or Other Material 1
Device Reprocessing Problem 1
Entrapment of Device 1
Fitting Problem 1
Improper or Incorrect Procedure or Method 1

Yearly Trend

03
2003: 7
04
2004: 14
05
2005: 61
06
2006: 99
07
2007: 68
08
2008: 87
09
2009: 232
10
2010: 305
11
2011: 314
12
2012: 1,957
13
2013: 3,497
14
2014: 1,928
15
2015: 1,733
16
2016: 1,528
17
2017: 799
18
2018: 179
19
2019: 37
20
2020: 31
21
2021: 23
22
2022: 8
23
2023: 14
24
2024: 36
25
2025: 52
26
2026: 4

Related Entities for Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

Event Locations

I 6,529 (50.2%)
5,971 (45.9%)
OTHER 322 (2.5%)
HOSPITAL 139 (1.1%)
NO INFORMATION 27 (0.2%)
HOME 20 (0.2%)
INVALID DATA 2 (0.0%)
UNKNOWN 2 (0.0%)
NURSING HOME 1 (0.0%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Filler, 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 (13,013 here).

Similar death-typed counts

Nearest other device types by death-typed report count (45 here), distinct from the volume row.

Disclaimer: MAUDE figures for Filler 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; 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.