Orthosis, Spinal Pedicle 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, Spinal Pedicle Fixation LIGHT-BOOK · MAUDE
#353 of 1000 · 3,989 reports · 1997–2026
- BOOK 3,989 reports
- RANK #353 of 1000
- DEATH 17 death-typed
- INJ 2,401 injury-typed
- MALF 1,517 malfunction
- SPAN 1997–2026
- PEAK 2013: 824
- PHOTO Electrode
Nearest event-volume peer: Electrode, Ion Specific, Sodium (4 report gap)
Orthosis, Spinal Pedicle Fixation sits #353 of 1000 among tracked device types with 3,989 MAUDE reports spanning 1997–2026. 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, Spinal Pedicle Fixation carries 60.2% INJURY-coded reports, 29.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
- INJ 60.2% corpus 30.3% · above corpus mean (+29.9 pp)
- MALF 38.0% corpus 64.8% · below corpus mean (-26.8 pp)
Lead product-problem code Break is 25% of coded problems · Lead manufacturer SYNTHES (USA) accounts for 38% of manufacturer-tagged reports · Top event location is 67% of location-tagged rows .
Orthosis, Spinal Pedicle Fixation in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Electrode
Electrode, Ion Specific, Sodium
3,993 reports
- Orthosis (this)
Orthosis, Spinal Pedicle Fixation
3,989 reports
- Suture
Suture, Nonabsorbable, Silk
3,979 reports
- Transducer
Transducer, Ultrasonic, Diagnostic
3,948 reports
- File
File, Pulp Canal, Endodontic
3,925 reports
- Transducer
Transducer, Blood-Pressure, Extravascular
3,904 reports
What this shows Orthosis, Spinal Pedicle Fixation carries 3,989 MAUDE reports, ranked #353 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 (81) held close to the prior two-year average of 118.
Related Entities for Orthosis, Spinal Pedicle Fixation
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Orthosis, Spinal Pedicle 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 (3,989 here).
Similar death-typed counts
Nearest other device types by death-typed report count (17 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Orthosis, Spinal Pedicle 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, Spinal Pedicle 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.