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 Class II (moderate risk, special controls required), regulated under 21 CFR §888.3080 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Intervertebral Fusion Device With Integrate… LIGHT-BOOK · MAUDE
#611 of 1000 · 1,268 reports · 2009–2026
- BOOK 1,268 reports
- RANK #611 of 1000
- DEATH 11 death-typed
- INJ 790 injury-typed
- MALF 461 malfunction
- SPAN 2009–2026
- PEAK 2021: 221
- PHOTO Tube, Feeding
Nearest event-volume peer: Tube, Feeding (2 report gap)
Intervertebral Fusion Device With Integrated Fixation, Lumbar sits #611 of 1000 among tracked device types with 1,268 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 →
Injury-coded reports run above the device-type norm
Intervertebral Fusion Device With Integrate… carries 62.3% INJURY-coded reports, 32.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.9% corpus 1.5% · below corpus mean (-0.6 pp)
- INJ 62.3% corpus 30.3% · above corpus mean (+32.0 pp)
- MALF 36.4% corpus 64.8% · below corpus mean (-28.5 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 34% of coded problems · Lead manufacturer OBERDORF SYNTHES PRODUKTIONS GMBH accounts for 38% of manufacturer-tagged reports · Top event location I is 65% 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
- Solid State X…
Solid State X-Ray Imager (Flat Panel/Digital Imager)
1,277 reports
- Stylet
Stylet, Catheter
1,275 reports
- Bone Mill
Bone Mill
1,273 reports
- Bed
Bed, Pediatric Open Hospital
1,272 reports
- Intervertebra… (this)
Intervertebral Fusion Device With Integrated Fixation, Lumbar
1,268 reports
- Tube, Feeding
Tube, Feeding
1,266 reports
What this shows Intervertebral Fusion Device With Integrated Fixation, Lumbar carries 1,268 MAUDE reports, ranked #611 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (52) held close to the prior two-year average of 80.
Related Entities for Intervertebral Fusion Device With Integrated Fixation, Lumbar
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Intervertebral Fusion Device With Integrate…: 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 (1,268 here).
Similar death-typed counts
Nearest other device types by death-typed report count (11 here), distinct from the volume row.
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.