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2026 data FDA MAUDE openFDA FDA Class II

Intervertebral Fusion Device With Integrated Fixation, Cervical

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 Integrate… LIGHT-BOOK · MAUDE

#458 of 1000 · 2,375 reports · 2004–2026

  • BOOK 2,375 reports
  • RANK #458 of 1000
  • DEATH 0 death-typed
  • INJ 813 injury-typed
  • MALF 1,551 malfunction
  • SPAN 2004–2026
  • PEAK 2013: 250
  • PHOTO Electrode

Nearest event-volume peer: Electrode, Electrosurgical, Active, Urological (3 report gap)

Intervertebral Fusion Device With Integrated Fixation, Cervical sits #458 of 1000 among tracked device types with 2,375 MAUDE reports spanning 2004–2026. 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 Integrate… carries 34.2% INJURY-coded reports, 3.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 34.2% corpus 30.3% · above corpus mean (+3.9 pp)
  • MALF 65.3% corpus 64.8% · near corpus mean (+0.5 pp)

Lead product-problem code Break is 29% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 49% of manufacturer-tagged reports · Top event location is 57% 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, Cervical carries 2,375 MAUDE reports, ranked #458 of 1000.

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

Event Types

Malfunction 1,551 (65.3%)
Injury 813 (34.2%)
Other 8 (0.3%)
3 (0.1%)

Patient Outcomes

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

1,486 (60.1%)
Required Intervention 624 (25.2%)
Other 185 (7.5%)
Hospitalization 50 (2.0%)
R 49 (2.0%)
H 22 (0.9%)
O 21 (0.8%)
S 19 (0.8%)
L 8 (0.3%)
Disability 4 (0.2%)
D 3 (0.1%)
Death 2 (0.1%)

Top Product Problems

Break 667
Adverse Event Without Identified Device or Use Problem 268
Fracture 186
Material Integrity Problem 129
Detachment of Device or Device Component 110
Detachment Of Device Component 87
Mechanical Problem 82
Difficult to Insert 77
Migration 74
Insufficient Device Problem Information 69
Device Operates Differently Than Expected 68
Material Twisted/Bent 64
Device Slipped 61
Migration or Expulsion of Device 61
Crack 57
Patient Device Interaction Problem 56
Device Dislodged or Dislocated 53
Material Separation 46
Compatibility Problem 44
Material Fragmentation 34

Yearly Trend

04
2004: 1
10
2010: 2
11
2011: 19
12
2012: 59
13
2013: 250
14
2014: 150
15
2015: 173
16
2016: 145
17
2017: 134
18
2018: 210
19
2019: 169
20
2020: 162
21
2021: 186
22
2022: 200
23
2023: 148
24
2024: 142
25
2025: 136
26
2026: 89

Reports in 2025 (136) held close to the prior two-year average of 145.

Related Entities for Intervertebral Fusion Device With Integrated Fixation, Cervical

Top Manufacturers

SYNTHES GMBH 492
SYNTHES USA 155
MDT SOFAMOR DANEK PUERTO RICO MFG 137
OBERDORF SYNTHES PRODUKTIONS GMBH 114
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 106

Event Locations

1,356 (57.1%)
I 993 (41.8%)
HOSPITAL 16 (0.7%)
NO INFORMATION 10 (0.4%)

Compare SYNTHES GMBH vs SYNTHES USA →

Nationwide devices with a comparable report-volume footprint

Intervertebral Fusion Device With Integrate… carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (2,375 here).

Electrode 2,372 Stimulator, Autonomic Nerve, Implanted 2,367 Transducer, Pressure, Catheter Tip 2,389 Electrode Measurement 2,392

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

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.