2026 data FDA MAUDE openFDA FDA Class II

Posterior Cervical 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 §888.3075 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Posterior Cervical Screw System LIGHT-BOOK · MAUDE

#475 of 1000 · 2,190 reports · 2015–2026

  • BOOK 2,190 reports
  • RANK #475 of 1000
  • DEATH 15 death-typed
  • INJ 1,428 injury-typed
  • MALF 747 malfunction
  • SPAN 2015–2026
  • PEAK 2021: 704
  • PHOTO Pin

Nearest event-volume peer: Pin, Fixation, Threaded (18 report gap)

Posterior Cervical Screw System sits #475 of 1000 among tracked device types with 2,190 MAUDE reports spanning 2015–2026. 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

Posterior Cervical Screw System carries 65.2% INJURY-coded reports, 34.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 65.2% corpus 30.3% · above corpus mean (+34.9 pp)
  • MALF 34.1% corpus 64.8% · below corpus mean (-30.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 33% of coded problems · Lead manufacturer WRIGHTS LANE SYNTHES USA PRODUCTS LLC accounts for 60% of manufacturer-tagged reports · Top event location I is 60% of location-tagged rows .

Posterior Cervical Screw System in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Posterior Cervical Screw System carries 2,190 MAUDE reports, ranked #475 of 1000.

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

Event Types

Injury 1,428 (65.2%)
Malfunction 747 (34.1%)
Death 15 (0.7%)

Patient Outcomes

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

Required Intervention 1,257 (56.1%)
712 (31.8%)
Other 147 (6.6%)
Hospitalization 51 (2.3%)
R 30 (1.3%)
O 13 (0.6%)
H 11 (0.5%)
Death 11 (0.5%)
S 3 (0.1%)
Disability 2 (0.1%)
Congenital Anomaly 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 731
Fracture 316
Break 294
Migration 284
Detachment of Device or Device Component 84
Insufficient Device Problem Information 67
Device-Device Incompatibility 50
Device Dislodged or Dislocated 45
Unintended Movement 43
Torn Material 42
Material Twisted/Bent 41
Material Integrity Problem 40
Material Separation 36
Mechanical Problem 28
Device Slipped 27
Patient Device Interaction Problem 27
Migration or Expulsion of Device 26
Loose or Intermittent Connection 21
Loosening of Implant Not Related to Bone-Ingrowth 20
Compatibility Problem 19

Yearly Trend

15
2015: 4
16
2016: 73
17
2017: 99
18
2018: 127
19
2019: 214
20
2020: 236
21
2021: 704
22
2022: 175
23
2023: 131
24
2024: 206
25
2025: 157
26
2026: 64

Reports in 2025 (157) held close to the prior two-year average of 169.

Related Entities for Posterior Cervical Screw System

Event Locations

I 1,315 (60.0%)
828 (37.8%)
HOSPITAL 43 (2.0%)
NO INFORMATION 4 (0.2%)

Compare WRIGHTS LANE SYNTHES USA PRODUCTS LLC vs OBERDORF SYNTHES PRODUKTIONS GMBH →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Posterior Cervical 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 (2,190 here).

Similar death-typed counts

Nearest other device types by death-typed report count (15 here), distinct from the volume row.

Disclaimer: MAUDE figures for Posterior Cervical 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 Posterior Cervical 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.