2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Thoracolumbosacral Pedicle Screw System MID-BOOK · MAUDE

#122 of 1000 · 24,083 reports · 2002–2026

  • BOOK 24,083 reports
  • RANK #122 of 1000
  • DEATH 86 death-typed
  • INJ 14,057 injury-typed
  • MALF 9,837 malfunction
  • SPAN 2002–2026
  • PEAK 2020: 2,076
  • PHOTO Programmer, Pacemaker

Nearest event-volume peer: Programmer, Pacemaker (356 report gap)

Thoracolumbosacral Pedicle Screw System sits #122 of 1000 among tracked device types with 24,083 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 58.4% corpus 30.4% · above corpus mean (+27.9 pp)
  • MALF 40.8% corpus 64.5% · below corpus mean (-23.7 pp)

Lead product-problem code Break is 18% of coded problems · Lead manufacturer DEPUY SYNTHES SPINE accounts for 23% of manufacturer-tagged reports · Top event location is 50% 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

reports

What this shows Thoracolumbosacral Pedicle Screw System carries 24,083 MAUDE reports, ranked #122 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 14,057 (58.4%)
Malfunction 9,837 (40.8%)
Death 86 (0.4%)
Other 54 (0.2%)
49 (0.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 10,904 (41.6%)
9,150 (34.9%)
Other 2,531 (9.7%)
R 1,645 (6.3%)
Hospitalization 1,323 (5.0%)
O 259 (1.0%)
H 202 (0.8%)
Death 100 (0.4%)
S 47 (0.2%)
Life Threatening 19 (0.1%)
L 15 (0.1%)
Disability 12 (0.0%)
D 3 (0.0%)
Congenital Anomaly 3 (0.0%)

Top Product Problems

Break 2,841
Adverse Event Without Identified Device or Use Problem 2,563
Fracture 1,764
Migration 1,462
Material Deformation 1,155
Loose or Intermittent Connection 632
Loosening of Implant Not Related to Bone-Ingrowth 627
Detachment of Device or Device Component 524
Device Slipped 516
Device Dislodged or Dislocated 514
Migration or Expulsion of Device 480
Material Twisted/Bent 479
Device-Device Incompatibility 310
Insufficient Information 292
Unintended Movement 286
Mechanical Problem 263
Device Operates Differently Than Expected 224
Appropriate Term/Code Not Available 201
Material Separation 161
Torn Material 158

Yearly Trend

02
2002: 2
03
2003: 4
04
2004: 10
05
2005: 6
06
2006: 8
07
2007: 34
08
2008: 82
09
2009: 171
10
2010: 462
11
2011: 577
12
2012: 1,747
13
2013: 1,962
14
2014: 1,670
15
2015: 1,446
16
2016: 1,585
17
2017: 1,618
18
2018: 1,684
19
2019: 1,915
20
2020: 2,076
21
2021: 1,745
22
2022: 1,339
23
2023: 919
24
2024: 1,616
25
2025: 1,188
26
2026: 217

Related Entities for Thoracolumbosacral Pedicle Screw System

Event Locations

12,002 (49.8%)
I 10,340 (42.9%)
HOSPITAL 1,624 (6.7%)
NO INFORMATION 63 (0.3%)
OTHER 27 (0.1%)
HOME 23 (0.1%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)
INVALID DATA 1 (0.0%)
OPERATING ROOM 1 (0.0%)

Compare DEPUY SYNTHES SPINE vs ZIMMER BIOMET SPINE INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Thoracolumbosacral Pedicle Screw System, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (24,083 here).

Similar death-typed counts

Nearest other device types by death-typed report count (86 here), distinct from the volume row.

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.