Thoracolumbosacral Pedicle Screw 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 Class II (moderate risk, special controls required), regulated under 21 CFR §888.3070 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Thoracolumbosacral Pedicle Screw System MID-BOOK · MAUDE
#125 of 1000 · 24,647 reports · 2002–2026
- BOOK 24,647 reports
- RANK #125 of 1000
- DEATH 86 death-typed
- INJ 14,335 injury-typed
- MALF 10,122 malfunction
- SPAN 2002–2026
- PEAK 2020: 2,076
- PHOTO Programmer, Pacemaker
Nearest event-volume peer: Programmer, Pacemaker (488 report gap)
Thoracolumbosacral Pedicle Screw System sits #125 of 1000 among tracked device types with 24,647 MAUDE reports spanning 2002–2026. 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
Thoracolumbosacral Pedicle Screw System carries 58.2% INJURY-coded reports, 27.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
- INJ 58.2% corpus 30.3% · above corpus mean (+27.9 pp)
- MALF 41.1% corpus 64.8% · below corpus mean (-23.8 pp)
Lead product-problem code Break is 22% of coded problems · Lead manufacturer DEPUY SYNTHES SPINE accounts for 23% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .
Thoracolumbosacral Pedicle Screw System in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Shunt
Shunt, Central Nervous System And Components
25,418 reports
- Mitral Valve…
Mitral Valve Repair Devices
25,400 reports
- Thoracolumbos… (this)
Thoracolumbosacral Pedicle Screw System
24,647 reports
- Programmer
Programmer, Pacemaker
24,159 reports
- Duodenoscope…
Duodenoscope And Accessories, Flexible/Rigid
24,101 reports
- Instrument
Instrument, Biopsy
23,840 reports
What this shows Thoracolumbosacral Pedicle Screw System carries 24,647 MAUDE reports, ranked #125 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 (1,187) held close to the prior two-year average of 1,266.
Related Entities for Thoracolumbosacral Pedicle Screw System
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Thoracolumbosacral Pedicle Screw System: 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 (24,647 here).
Similar death-typed counts
Nearest other device types by death-typed report count (86 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Thoracolumbosacral Pedicle Screw System 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 Thoracolumbosacral Pedicle Screw System; 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.