Orthosis, Spondylolisthesis Spinal Fixation
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 §888.3070 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Orthosis, Spondylolisthesis Spinal Fixation LIGHT-BOOK · MAUDE
#342 of 1000 · 4,392 reports · 1996–2026
- BOOK 4,392 reports
- RANK #342 of 1000
- DEATH 2 death-typed
- INJ 2,820 injury-typed
- MALF 1,538 malfunction
- SPAN 1996–2026
- PEAK 2021: 531
- PHOTO System
Nearest event-volume peer: System, Hypothermia, Intravenous, Cooling (3 report gap)
Orthosis, Spondylolisthesis Spinal Fixation sits #342 of 1000 among tracked device types with 4,392 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
Orthosis, Spondylolisthesis Spinal Fixation carries 64.2% INJURY-coded reports, 33.9pp 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 64.2% corpus 30.3% · above corpus mean (+33.9 pp)
- MALF 35.0% corpus 64.8% · below corpus mean (-29.8 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 22% of coded problems · Lead manufacturer OBERDORF SYNTHES PRODUKTIONS GMBH accounts for 21% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .
Orthosis, Spondylolisthesis Spinal Fixation in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Pack
Pack, Hot Or Cold, Disposable
4,404 reports
- Orthosis (this)
Orthosis, Spondylolisthesis Spinal Fixation
4,392 reports
- System
System, Hypothermia, Intravenous, Cooling
4,389 reports
- Intestinal St…
Intestinal Stimulator
4,382 reports
- Implant
Implant, Eye Valve
4,379 reports
- Pump
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
4,355 reports
What this shows Orthosis, Spondylolisthesis Spinal Fixation carries 4,392 MAUDE reports, ranked #342 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 fell to 91 in 2025, down from an average of 212 in the two years before.
Related Entities for Orthosis, Spondylolisthesis Spinal Fixation
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Orthosis, Spondylolisthesis Spinal Fixation: 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 (4,392 here).
Similar death-typed counts
Nearest other device types by death-typed report count (2 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Orthosis, Spondylolisthesis Spinal Fixation 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 Orthosis, Spondylolisthesis Spinal Fixation; 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.