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2026 data FDA MAUDE openFDA FDA Class III

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.

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

#418 of 1000 · 2,908 reports · 2005–2026

  • BOOK 2,908 reports
  • RANK #418 of 1000
  • DEATH 5 death-typed
  • INJ 1,310 injury-typed
  • MALF 1,499 malfunction
  • SPAN 2005–2026
  • PEAK 2025: 767
  • PHOTO Implanted Subcortical…

Nearest event-volume peer: Implanted Subcortical Electrical Stimulator (Motor Disorders) (1 report gap)

Prosthesis, Spinous Process Spacer/Plate sits #418 of 1000 among tracked device types with 2,908 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 →

Injury-coded reports run above the device-type norm

Prosthesis, Spinous Process Spacer/Plate carries 45.0% INJURY-coded reports, 14.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 45.0% corpus 30.3% · above corpus mean (+14.8 pp)
  • MALF 51.5% corpus 64.8% · below corpus mean (-13.3 pp)

Lead product-problem code Material Integrity Problem is 41% 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 2,908 MAUDE reports, ranked #418 of 1000.

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

Event Types

Malfunction 1,499 (51.5%)
Injury 1,310 (45.0%)
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 (48.1%)
Required Intervention 903 (30.0%)
Other 505 (16.8%)
R 79 (2.6%)
Hospitalization 33 (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 656
Insufficient Device Problem Information 249
Migration 222
Difficult to Open or Close 179
Device Dislodged or Dislocated 96
Lack of Effect 90
Migration or Expulsion of Device 56
Material Twisted/Bent 50
No Apparent Adverse Event 37
Explanted 33
Malposition of Device 26
Fracture 24
Unknown (for use when the device problem is not known) 22
Appropriate Device Problem Term/Code Not Available 21
Inadequacy of Device Shape and/or Size 20
Break 18
Physical Resistance/Sticking 17
Defective Device 14
Device Operates Differently Than Expected 12

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: 19

Reports rose to 767 in 2025, up from an average of 205 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Prosthesis, Spinous Process Spacer/Plate

Top Manufacturers

BOSTON SCIENTIFIC NEUROMODULATION 1,076
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION 840
MEDTRONIC SOFAMOR DANEK 93
MEDTRONIC SOFAMOR DANEK USA, INC 52

Event Locations

2,208 (75.9%)
I 685 (23.6%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis, Spinous Process Spacer/Plate: 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 (2,908 here).

Implanted Subcortical Electrical Stimulator 2,909 Aid, Surgical, Viscoelastic 2,928 Spinal Vertebral Body Replacement Device 2,930 Lithotriptor, Biliary Mechanical 2,875

Similar death-typed counts

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

Anesthesia Conduction Kit 5 Antigens, All Groups, Streptococcus Spp. 5 Apparatus, Exhaust, Surgical 5 Bit, Drill 5

Read our methodology - how this data is sourced, computed, and verified.

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.