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2026 data FDA MAUDE openFDA FDA Class II

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.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §888.3080 (Orthopedic panel).

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FDA MAUDE casebook

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

#227 of 1000 · 9,183 reports · 1996–2026

  • BOOK 9,183 reports
  • RANK #227 of 1000
  • DEATH 30 death-typed
  • INJ 3,278 injury-typed
  • MALF 5,801 malfunction
  • SPAN 1996–2026
  • PEAK 2025: 826
  • PHOTO Controller

Nearest event-volume peer: Controller, Temperature, Cardiopulmonary Bypass (18 report gap)

Intervertebral Fusion Device With Bone Graft, Lumbar sits #227 of 1000 among tracked device types with 9,183 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 →

Injury-coded reports run above the device-type norm

Intervertebral Fusion Device With Bone Graft carries 35.7% INJURY-coded reports, 5.4pp 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 35.7% corpus 30.3% · above corpus mean (+5.4 pp)
  • MALF 63.2% corpus 64.8% · below corpus mean (-1.7 pp)

Lead product-problem code Break is 30% of coded problems · Lead manufacturer MEDTRONIC SOFAMOR DANEK USA, INC accounts for 33% of manufacturer-tagged reports · Top event location is 52% 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 9,183 MAUDE reports, ranked #227 of 1000.

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

Event Types

Malfunction 5,801 (63.2%)
Injury 3,278 (35.7%)
Other 44 (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.

5,420 (56.9%)
Required Intervention 2,119 (22.2%)
Other 1,210 (12.7%)
R 294 (3.1%)
Hospitalization 244 (2.6%)
O 57 (0.6%)
H 42 (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 2,638
Adverse Event Without Identified Device or Use Problem 989
Migration 774
Fracture 772
Migration or Expulsion of Device 624
Mechanical Problem 522
Device-Device Incompatibility 439
Collapse 208
Material Deformation 197
Device Dislodged or Dislocated 188
Insufficient Device Problem Information 186
Material Integrity Problem 181
Device Operates Differently Than Expected 179
Mechanical Jam 168
Compatibility Problem 139
Crack 131
Detachment Of Device Component 130
Mechanics Altered 120
Difficult to Insert 118
Malposition of Device 118

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: 412

Reports in 2025 (826) held close to the prior two-year average of 653.

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
OBERDORF SYNTHES PRODUKTIONS GMBH 255

Event Locations

4,787 (52.1%)
I 3,944 (42.9%)
HOSPITAL 335 (3.6%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Intervertebral Fusion Device With Bone Graft: 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 (9,183 here).

Controller 9,165 Negative Pressure Wound Therapy Powered Suc… 9,164 Catheter, Retention Type, Balloon 9,331 Prosthesis 9,364

Similar death-typed counts

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

Apparatus, Nitric Oxide Delivery 30 Barrier, Absorbable, Adhesion 30 Bed, Patient Rotation, Powered 30 Cannula, Nasal, Oxygen 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.