Appliance, Fixation, Spinal Intervertebral Body
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 §888.3060 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Appliance MID-BOOK · MAUDE
#212 of 1000 · 10,554 reports · 1993–2026
- BOOK 10,554 reports
- RANK #212 of 1000
- DEATH 59 death-typed
- INJ 5,708 injury-typed
- MALF 4,480 malfunction
- SPAN 1993–2026
- PEAK 2013: 796
- PHOTO Stent
Nearest event-volume peer: Stent, Superficial Femoral Artery (19 report gap)
Appliance, Fixation, Spinal Intervertebral Body sits #212 of 1000 among tracked device types with 10,554 MAUDE reports spanning 1993–2026. 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
Appliance carries 54.1% INJURY-coded reports, 23.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
- INJ 54.1% corpus 30.3% · above corpus mean (+23.8 pp)
- MALF 42.4% corpus 64.8% · below corpus mean (-22.4 pp)
Lead product-problem code Break is 20% of coded problems · Lead manufacturer SYNTHES (USA) accounts for 31% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .
Appliance in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Ligator
Ligator, Esophageal
10,683 reports
- Walker
Walker, Mechanical
10,673 reports
- Cystoscope An…
Cystoscope And Accessories, Flexible/Rigid
10,640 reports
- Oxygenator
Oxygenator, Cardiopulmonary Bypass
10,612 reports
- Stent
Stent, Superficial Femoral Artery
10,573 reports
- Appliance (this)
Appliance, Fixation, Spinal Intervertebral Body
10,554 reports
What this shows Appliance, Fixation, Spinal Intervertebral Body carries 10,554 MAUDE reports, ranked #212 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 (251) held close to the prior two-year average of 370.
Related Entities for Appliance, Fixation, Spinal Intervertebral Body
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Appliance: 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 (10,554 here).
Similar death-typed counts
Nearest other device types by death-typed report count (59 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Appliance 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 Appliance; 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.