Spinal Pedicle Screw, Fixation, Appliance System
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 MAUDE casebook
openFDA event book Spinal Pedicle Screw LIGHT-BOOK · MAUDE
#629 of 1000 · 1,178 reports · 1992–2019
- BOOK 1,178 reports
- RANK #629 of 1000
- DEATH 8 death-typed
- INJ 782 injury-typed
- MALF 226 malfunction
- SPAN 1992–2019
- PEAK 1994: 292
- PHOTO Holder
Nearest event-volume peer: Holder, Ureteral Catheter (1 report gap)
Spinal Pedicle Screw, Fixation, Appliance System sits #629 of 1000 among tracked device types with 1,178 MAUDE reports spanning 1992–2019. 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 →
Malfunction reports sit below the device-type norm
Spinal Pedicle Screw carries 19.2% MALFUNCTION-coded reports, 45.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
- INJ 66.4% corpus 30.3% · above corpus mean (+36.1 pp)
- MALF 19.2% corpus 64.8% · below corpus mean (-45.6 pp)
Lead product-problem code Break is 23% of coded problems · Lead manufacturer UNKNOWN accounts for 77% of manufacturer-tagged reports · Top event location is 33% of location-tagged rows .
Spinal Pedicle Screw in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- System
System, Monitoring, Perinatal
1,183 reports
- Bed
Bed, Flotation Therapy, Powered
1,182 reports
- Endovascular…
Endovascular Suturing System
1,181 reports
- Spinal Pedicl… (this)
Spinal Pedicle Screw, Fixation, Appliance System
1,178 reports
- Holder
Holder, Ureteral Catheter
1,177 reports
- Filter
Filter, Infusion Line
1,167 reports
What this shows Spinal Pedicle Screw, Fixation, Appliance System carries 1,178 MAUDE reports, ranked #629 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 1 in 2016, down from an average of 16 in the two years before.
Related Entities for Spinal Pedicle Screw, Fixation, Appliance System
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Spinal Pedicle Screw: 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 (1,178 here).
Similar death-typed counts
Nearest other device types by death-typed report count (8 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Spinal Pedicle Screw 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 Spinal Pedicle Screw; 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.