2019 data FDA MAUDE openFDA

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

#614 of 1000 · 1,178 reports · 1992–2019

  • BOOK 1,178 reports
  • RANK #614 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 (5 report gap)

Spinal Pedicle Screw, Fixation, Appliance System sits #614 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 →

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 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 66.4% corpus 30.4% · above corpus mean (+35.9 pp)
  • MALF 19.2% corpus 64.5% · below corpus mean (-45.3 pp)

Lead product-problem code Break is 25% 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

reports

What this shows Spinal Pedicle Screw, Fixation, Appliance System carries 1,178 MAUDE reports, ranked #614 of 1000.

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

Event Types

Injury 782 (66.4%)
Malfunction 226 (19.2%)
Other 112 (9.5%)
50 (4.2%)
Death 8 (0.7%)

Patient Outcomes

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

S 287 (16.6%)
248 (14.3%)
Hospitalization 238 (13.7%)
Required Intervention 230 (13.3%)
Disability 209 (12.1%)
Other 207 (12.0%)
R 151 (8.7%)
O 63 (3.6%)
L 35 (2.0%)
Congenital Anomaly 18 (1.0%)
H 17 (1.0%)
Life Threatening 14 (0.8%)
Death 7 (0.4%)
Not Applicable 7 (0.4%)
C 1 (0.1%)

Top Product Problems

Break 1
Migration 1
Noise, Audible 1
Unintended Ejection 1

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 292
95
1995: 280
96
1996: 36
97
1997: 34
98
1998: 26
99
1999: 21
00
2000: 17
01
2001: 18
02
2002: 24
03
2003: 53
04
2004: 32
05
2005: 26
06
2006: 34
07
2007: 69
08
2008: 52
09
2009: 25
10
2010: 11
11
2011: 1
12
2012: 8
13
2013: 83
14
2014: 30
15
2015: 2
16
2016: 1
19
2019: 1

Related Entities for Spinal Pedicle Screw, Fixation, Appliance System

Top Manufacturers

Event Locations

393 (33.4%)
NO INFORMATION 332 (28.2%)
NOT APPLICABLE 180 (15.3%)
HOSPITAL 133 (11.3%)
INVALID DATA 56 (4.8%)
HOME 39 (3.3%)
UNKNOWN 39 (3.3%)
OTHER 5 (0.4%)
I 1 (0.1%)

Compare UNKNOWN vs DEPUY SYNTHES SPINE →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Spinal Pedicle Screw, 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 (1,178 here).

Similar death-typed counts

Nearest other device types by death-typed report count (8 here), distinct from the volume row.

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.