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2026 data FDA MAUDE openFDA FDA Class III

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.

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FDA MAUDE casebook

openFDA event book Filler MID-BOOK · MAUDE

#186 of 1000 · 13,040 reports · 2003–2026

  • BOOK 13,040 reports
  • RANK #186 of 1000
  • DEATH 45 death-typed
  • INJ 12,845 injury-typed
  • MALF 90 malfunction
  • SPAN 2003–2026
  • PEAK 2013: 3,497
  • PHOTO Pulse-Generator

Nearest event-volume peer: Pulse-Generator, Pacemaker, External (26 report gap)

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction sits #186 of 1000 among tracked device types with 13,040 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 →

Injury-coded reports run above the device-type norm

Filler carries 98.5% INJURY-coded reports, 68.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 98.5% corpus 30.3% · above corpus mean (+68.2 pp)
  • MALF 0.7% corpus 64.8% · below corpus mean (-64.1 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 85% 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 13,040 MAUDE reports, ranked #186 of 1000.

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

Event Types

Injury 12,845 (98.5%)
Malfunction 90 (0.7%)
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 8,306 (58.2%)
Required Intervention 3,803 (26.7%)
R 903 (6.3%)
488 (3.4%)
Hospitalization 300 (2.1%)
S 200 (1.4%)
O 72 (0.5%)
Disability 55 (0.4%)
L 47 (0.3%)
Death 45 (0.3%)
Life Threatening 36 (0.3%)
H 6 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 11,131
Insufficient Device Problem Information 1,004
Unknown (for use when the device problem is not known) 210
Device remains implanted 118
Device Operates Differently Than Expected 91
Off-Label Use 81
No Apparent Adverse Event 69
Explanted 58
Appropriate Device Problem Term/Code Not Available 50
Migration or Expulsion of Device 49
Patient-Device Incompatibility 39
Break 23
Osseointegration Problem 23
Improper or Incorrect Procedure or Method 21
Replace 21
Other (for use when an appropriate device code cannot be identified) 11
Malposition of Device 10
Failure to Osseointegrate 9
Nonstandard Device 9
Device Slipped 8

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: 31

Reports rose to 52 in 2025, up from an average of 25 in the two years before - a recent-year increase, not a lifetime pattern.

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

Top Manufacturers

MEDTRONIC SOFAMOR DANEK USA, INC 11,204
MEDTRONIC SOFAMOR DANEK USA, INC. 851
MEDTRONIC, INC. 303
MEDTRONIC SOFAMOR DANEK 245
MEDTRONIC, INC 106
MEDTRONIC INC 72
MEDTRONIC 65
MEDTRONIC INC. 29

Event Locations

I 6,529 (50.1%)
5,998 (46.0%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Filler: 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 (13,040 here).

Pulse-Generator, Pacemaker, External 13,014 Clamp, Vascular 12,982 Bone Cement 13,130 Electrode, Ph, Stomach 12,853

Similar death-typed counts

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

Glue, Surgical, Arteries 45 Monitor, Physiological, Patient 45 System, Ablation, Microwave And Accessories 45 Catheter, Peritoneal, Long-Term Indwelling 46

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

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.