2026 data FDA MAUDE openFDA FDA Class III

Prosthesis, Intervertebral Disc

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, Intervertebral Disc LIGHT-BOOK · MAUDE

#284 of 1000 · 6,148 reports · 2003–2026

  • BOOK 6,148 reports
  • RANK #284 of 1000
  • DEATH 11 death-typed
  • INJ 5,056 injury-typed
  • MALF 1,054 malfunction
  • SPAN 2003–2026
  • PEAK 2015: 724
  • PHOTO Suture

Nearest event-volume peer: Suture, Nonabsorbable, Synthetic, Polyamide (57 report gap)

Prosthesis, Intervertebral Disc sits #284 of 1000 among tracked device types with 6,148 MAUDE reports spanning 2003–2026. 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, Intervertebral Disc carries 82.2% INJURY-coded reports, 51.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 82.2% corpus 30.3% · above corpus mean (+51.9 pp)
  • MALF 17.1% corpus 64.8% · below corpus mean (-47.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 24% of coded problems · Lead manufacturer SYNTHES BRANDYWINE accounts for 63% of manufacturer-tagged reports · Top event location is 66% of location-tagged rows .

Prosthesis, Intervertebral Disc in the event-volume neighbourhood

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

reports

What this shows Prosthesis, Intervertebral Disc carries 6,148 MAUDE reports, ranked #284 of 1000.

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

Event Types

Injury 5,056 (82.2%)
Malfunction 1,054 (17.1%)
20 (0.3%)
Death 11 (0.2%)
Other 7 (0.1%)

Patient Outcomes

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

Required Intervention 3,686 (53.5%)
1,314 (19.1%)
Other 712 (10.3%)
R 393 (5.7%)
Hospitalization 340 (4.9%)
O 126 (1.8%)
S 99 (1.4%)
H 88 (1.3%)
Disability 65 (0.9%)
L 41 (0.6%)
Life Threatening 17 (0.2%)
Death 7 (0.1%)
Congenital Anomaly 4 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,462
Insufficient Device Problem Information 873
Migration or Expulsion of Device 699
Migration 389
Device remains implanted 349
Patient-Device Incompatibility 252
Explanted 212
Malposition of Device 204
Detachment of Device or Device Component 201
Device Dislodged or Dislocated 186
Appropriate Device Problem Term/Code Not Available 176
Break 165
Patient Device Interaction Problem 152
Device Slipped 124
Collapse 103
Device Operates Differently Than Expected 102
Fracture 95
Positioning Problem 93
Expulsion 81
Mechanical Problem 76

Yearly Trend

03
2003: 1
04
2004: 3
05
2005: 115
06
2006: 80
07
2007: 278
08
2008: 104
09
2009: 283
10
2010: 174
11
2011: 251
12
2012: 314
13
2013: 371
14
2014: 328
15
2015: 724
16
2016: 161
17
2017: 277
18
2018: 369
19
2019: 380
20
2020: 345
21
2021: 308
22
2022: 263
23
2023: 278
24
2024: 315
25
2025: 265
26
2026: 161

Reports in 2025 (265) held close to the prior two-year average of 297.

Related Entities for Prosthesis, Intervertebral Disc

Top Manufacturers

Event Locations

4,046 (65.8%)
I 1,872 (30.4%)
HOSPITAL 158 (2.6%)
NO INFORMATION 30 (0.5%)
OTHER 20 (0.3%)
HOME 13 (0.2%)
UNKNOWN 8 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare SYNTHES BRANDYWINE vs DEPUY SPINE, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis, Intervertebral Disc: 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 (6,148 here).

Similar death-typed counts

Nearest other device types by death-typed report count (11 here), distinct from the volume row.

Disclaimer: MAUDE figures for Prosthesis, Intervertebral Disc 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, Intervertebral Disc; 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.