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2026 data FDA MAUDE openFDA

Intervertebral Fusion Device With Bone Graft, Lumbar

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

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FDA MAUDE casebook

openFDA event book Intervertebral Fusion Device With Bone Graft LIGHT-BOOK · MAUDE

#226 of 1000 · 8,876 reports · 1996–2026

  • BOOK 8,876 reports
  • RANK #226 of 1000
  • DEATH 30 death-typed
  • INJ 3,219 injury-typed
  • MALF 5,554 malfunction
  • SPAN 1996–2026
  • PEAK 2025: 826
  • PHOTO Controller

Nearest event-volume peer: Controller, Temperature, Cardiopulmonary Bypass (17 report gap)

Intervertebral Fusion Device With Bone Graft, Lumbar sits #226 of 1000 among tracked device types with 8,876 MAUDE reports spanning 1996–2026. 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 36.3% corpus 30.4% · above corpus mean (+5.8 pp)
  • MALF 62.6% corpus 64.5% · below corpus mean (-1.9 pp)

Lead product-problem code Break is 26% of coded problems · Lead manufacturer MEDTRONIC SOFAMOR DANEK USA, INC accounts for 26% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .

Intervertebral Fusion Device With Bone Graft in the event-volume neighbourhood

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

reports

What this shows Intervertebral Fusion Device With Bone Graft, Lumbar carries 8,876 MAUDE reports, ranked #226 of 1000.

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

Event Types

Malfunction 5,554 (62.6%)
Injury 3,219 (36.3%)
Other 43 (0.5%)
30 (0.3%)
Death 30 (0.3%)

Patient Outcomes

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

5,260 (56.5%)
Required Intervention 2,079 (22.3%)
Other 1,199 (12.9%)
R 293 (3.1%)
Hospitalization 242 (2.6%)
O 57 (0.6%)
H 40 (0.4%)
S 38 (0.4%)
Disability 38 (0.4%)
Death 31 (0.3%)
L 15 (0.2%)
Life Threatening 15 (0.2%)
Congenital Anomaly 3 (0.0%)
D 1 (0.0%)

Top Product Problems

Break 1,712
Adverse Event Without Identified Device or Use Problem 815
Migration 741
Fracture 603
Mechanical Problem 427
Device-Device Incompatibility 425
Migration or Expulsion of Device 349
Material Deformation 167
Material Integrity Problem 166
Collapse 158
Mechanical Jam 152
Compatibility Problem 137
Insufficient Information 133
Device Dislodged or Dislocated 110
Mechanics Altered 108
Appropriate Term/Code Not Available 89
Device Operates Differently Than Expected 89
Material Fragmentation 79
Detachment of Device or Device Component 78
Use of Device Problem 74

Yearly Trend

96
1996: 1
97
1997: 2
98
1998: 20
99
1999: 11
00
2000: 13
01
2001: 10
02
2002: 17
03
2003: 21
04
2004: 8
05
2005: 15
06
2006: 11
07
2007: 12
08
2008: 19
09
2009: 90
10
2010: 154
11
2011: 201
12
2012: 327
13
2013: 380
14
2014: 366
15
2015: 524
16
2016: 647
17
2017: 596
18
2018: 616
19
2019: 699
20
2020: 640
21
2021: 622
22
2022: 618
23
2023: 576
24
2024: 729
25
2025: 826
26
2026: 105

Related Entities for Intervertebral Fusion Device With Bone Graft, Lumbar

Top Manufacturers

MEDTRONIC SOFAMOR DANEK USA, INC 580
MDT SOFAMOR DANEK PUERTO RICO MFG 483
SYNTHES GMBH 441
WARSAW ORTHOPEDICS 434
OBERDORF SYNTHES PRODUKTIONS GMBH 255

Event Locations

4,480 (50.5%)
I 3,945 (44.4%)
HOSPITAL 334 (3.8%)
NO INFORMATION 55 (0.6%)
UNKNOWN 24 (0.3%)
OTHER 16 (0.2%)
HOME 14 (0.2%)
NOT APPLICABLE 5 (0.1%)
CLINIC - WALK IN, OTHER 1 (0.0%)
INVALID DATA 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare MEDTRONIC SOFAMOR DANEK USA, INC vs MDT SOFAMOR DANEK PUERTO RICO MFG →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Intervertebral Fusion Device With Bone Graft, 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 (8,876 here).

Controller 8,893 Catheter, Retention Type, Balloon 8,858 Prosthesis 8,981 Motor, Drill, Pneumatic 8,734

Similar death-typed counts

Nearest other device types by death-typed report count (30 here), distinct from the volume row.

Barrier, Absorbable, Adhesion 30 Bed, Patient Rotation, Powered 30 Cannula, Nasal, Oxygen 30 Carboxymethylcellulose Sodium Or Polyvinyl… 30

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

Disclaimer: MAUDE figures for Intervertebral Fusion Device With Bone Graft 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 Intervertebral Fusion Device With Bone Graft; 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.