2026 data FDA MAUDE openFDA

Prosthesis, Spinous Process Spacer/Plate

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 Prosthesis, Spinous Process Spacer/Plate LIGHT-BOOK · MAUDE

#406 of 1000 · 2,895 reports · 2005–2026

  • BOOK 2,895 reports
  • RANK #406 of 1000
  • DEATH 5 death-typed
  • INJ 1,301 injury-typed
  • MALF 1,495 malfunction
  • SPAN 2005–2026
  • PEAK 2025: 767
  • PHOTO Light Source

Nearest event-volume peer: Light Source, Fiberoptic, Routine (10 report gap)

Prosthesis, Spinous Process Spacer/Plate sits #406 of 1000 among tracked device types with 2,895 MAUDE reports spanning 2005–2026. 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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 44.9% corpus 30.4% · above corpus mean (+14.5 pp)
  • MALF 51.6% corpus 64.5% · below corpus mean (-12.9 pp)

Lead product-problem code Material Integrity Problem is 50% of coded problems · Lead manufacturer BOSTON SCIENTIFIC NEUROMODULATION accounts for 52% of manufacturer-tagged reports · Top event location is 76% of location-tagged rows .

Prosthesis, Spinous Process Spacer/Plate in the event-volume neighbourhood

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

reports

What this shows Prosthesis, Spinous Process Spacer/Plate carries 2,895 MAUDE reports, ranked #406 of 1000.

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

Event Types

Malfunction 1,495 (51.6%)
Injury 1,301 (44.9%)
Other 85 (2.9%)
9 (0.3%)
Death 5 (0.2%)

Patient Outcomes

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

1,447 (48.3%)
Required Intervention 896 (29.9%)
Other 501 (16.7%)
R 78 (2.6%)
Hospitalization 32 (1.1%)
O 15 (0.5%)
H 7 (0.2%)
S 5 (0.2%)
Disability 5 (0.2%)
Life Threatening 5 (0.2%)
Death 4 (0.1%)
L 1 (0.0%)

Top Product Problems

Material Integrity Problem 1,274
Adverse Event Without Identified Device or Use Problem 573
Migration 220
Difficult to Open or Close 177
Lack of Effect 84
Device Dislodged or Dislocated 70
Material Twisted/Bent 49
Physical Resistance/Sticking 17
Malposition of Device 15
Defective Device 14
Break 12
Migration or Expulsion of Device 12
Insufficient Information 10
Fracture 6
Use of Device Problem 6
Mechanical Problem 5
Nonstandard Device 5
Appropriate Term/Code Not Available 4
Improper or Incorrect Procedure or Method 4
Difficult or Delayed Positioning 3

Yearly Trend

05
2005: 2
06
2006: 18
07
2007: 19
08
2008: 29
09
2009: 205
10
2010: 127
11
2011: 33
12
2012: 32
13
2013: 64
14
2014: 42
15
2015: 33
16
2016: 31
17
2017: 34
18
2018: 17
19
2019: 2
20
2020: 206
21
2021: 474
22
2022: 345
23
2023: 250
24
2024: 159
25
2025: 767
26
2026: 6

Related Entities for Prosthesis, Spinous Process Spacer/Plate

Event Locations

2,195 (75.8%)
I 685 (23.7%)
NO INFORMATION 9 (0.3%)
HOSPITAL 5 (0.2%)
OTHER 1 (0.0%)

Compare BOSTON SCIENTIFIC NEUROMODULATION vs BOSTON SCIENTIFIC NEUROMODULATION CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Prosthesis, Spinous Process Spacer/Plate, 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 (2,895 here).

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Disclaimer: MAUDE figures for Prosthesis, Spinous Process Spacer/Plate 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 Prosthesis, Spinous Process Spacer/Plate; 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.