2026 data FDA MAUDE openFDA

Intervertebral Fusion Device With Integrated Fixation, 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 MAUDE casebook

openFDA event book Intervertebral Fusion Device With Integrate… LIGHT-BOOK · MAUDE

#598 of 1000 · 1,246 reports · 2009–2026

  • BOOK 1,246 reports
  • RANK #598 of 1000
  • DEATH 11 death-typed
  • INJ 786 injury-typed
  • MALF 443 malfunction
  • SPAN 2009–2026
  • PEAK 2021: 221
  • PHOTO System

Nearest event-volume peer: System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy (2 report gap)

Intervertebral Fusion Device With Integrated Fixation, Lumbar sits #598 of 1000 among tracked device types with 1,246 MAUDE reports spanning 2009–2026. 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 0.9% corpus 1.5% · below corpus mean (-0.6 pp)
  • INJ 63.1% corpus 30.4% · above corpus mean (+32.6 pp)
  • MALF 35.6% corpus 64.5% · below corpus mean (-29.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 36% of coded problems · Lead manufacturer OBERDORF SYNTHES PRODUKTIONS GMBH accounts for 39% of manufacturer-tagged reports · Top event location I is 66% of location-tagged rows .

Intervertebral Fusion Device With Integrate… 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 Integrated Fixation, Lumbar carries 1,246 MAUDE reports, ranked #598 of 1000.

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

Event Types

Injury 786 (63.1%)
Malfunction 443 (35.6%)
Death 11 (0.9%)
4 (0.3%)
Other 2 (0.2%)

Patient Outcomes

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

Required Intervention 594 (45.4%)
409 (31.3%)
Other 170 (13.0%)
Hospitalization 59 (4.5%)
R 42 (3.2%)
O 14 (1.1%)
Death 10 (0.8%)
S 3 (0.2%)
Disability 2 (0.2%)
Life Threatening 2 (0.2%)
D 1 (0.1%)
H 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 404
Break 157
Migration 121
Fracture 71
Patient Device Interaction Problem 36
Migration or Expulsion of Device 35
Appropriate Term/Code Not Available 34
No Apparent Adverse Event 33
Detachment of Device or Device Component 31
Material Separation 25
Device Dislodged or Dislocated 22
Unintended Movement 20
Device-Device Incompatibility 19
Compatibility Problem 17
Positioning Problem 17
Insufficient Information 16
Material Deformation 15
Crack 14
Difficult to Insert 14
Material Integrity Problem 14

Yearly Trend

09
2009: 2
10
2010: 2
11
2011: 6
12
2012: 16
13
2013: 16
14
2014: 35
15
2015: 43
16
2016: 55
17
2017: 72
18
2018: 112
19
2019: 171
20
2020: 203
21
2021: 221
22
2022: 74
23
2023: 67
24
2024: 92
25
2025: 51
26
2026: 8

Related Entities for Intervertebral Fusion Device With Integrated Fixation, Lumbar

Event Locations

I 828 (66.5%)
401 (32.2%)
HOSPITAL 11 (0.9%)
NO INFORMATION 5 (0.4%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)

Compare OBERDORF SYNTHES PRODUKTIONS GMBH vs SYNTHES GMBH →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Intervertebral Fusion Device With Integrate…, 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 (1,246 here).

Similar death-typed counts

Nearest other device types by death-typed report count (11 here), distinct from the volume row.

Disclaimer: MAUDE figures for Intervertebral Fusion Device With Integrate… 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 Integrate…; 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.