2026 data FDA MAUDE openFDA

Appliance, Fixation, Spinal Intervertebral Body

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 Appliance MID-BOOK · MAUDE

#207 of 1000 · 10,368 reports · 1993–2026

  • BOOK 10,368 reports
  • RANK #207 of 1000
  • DEATH 59 death-typed
  • INJ 5,617 injury-typed
  • MALF 4,385 malfunction
  • SPAN 1993–2026
  • PEAK 2013: 796
  • PHOTO System

Nearest event-volume peer: System, Test, Automated Blood Grouping And Antibody (14 report gap)

Appliance, Fixation, Spinal Intervertebral Body sits #207 of 1000 among tracked device types with 10,368 MAUDE reports spanning 1993–2026. 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 0.6% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 54.2% corpus 30.4% · above corpus mean (+23.7 pp)
  • MALF 42.3% corpus 64.5% · below corpus mean (-22.2 pp)

Lead product-problem code Break is 15% of coded problems · Lead manufacturer SYNTHES (USA) accounts for 27% of manufacturer-tagged reports · Top event location is 64% of location-tagged rows .

Appliance in the event-volume neighbourhood

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

reports

What this shows Appliance, Fixation, Spinal Intervertebral Body carries 10,368 MAUDE reports, ranked #207 of 1000.

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

Event Types

Injury 5,617 (54.2%)
Malfunction 4,385 (42.3%)
Other 246 (2.4%)
61 (0.6%)
Death 59 (0.6%)

Patient Outcomes

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

Required Intervention 4,513 (41.0%)
3,621 (32.9%)
Other 1,610 (14.6%)
R 479 (4.3%)
Hospitalization 464 (4.2%)
O 74 (0.7%)
Disability 68 (0.6%)
Death 59 (0.5%)
S 58 (0.5%)
H 25 (0.2%)
L 16 (0.1%)
Life Threatening 13 (0.1%)
Not Applicable 9 (0.1%)
Congenital Anomaly 4 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Break 629
Adverse Event Without Identified Device or Use Problem 596
Fracture 595
Migration 470
Migration or Expulsion of Device 226
Device Dislodged or Dislocated 192
Material Integrity Problem 170
Detachment of Device or Device Component 144
Mechanical Problem 133
Insufficient Information 126
Device Slipped 110
Material Deformation 99
Material Fragmentation 86
Loose or Intermittent Connection 81
Device Operates Differently Than Expected 80
Material Twisted/Bent 78
Patient Device Interaction Problem 68
Unintended Movement 67
Device-Device Incompatibility 56
Loosening of Implant Not Related to Bone-Ingrowth 54

Yearly Trend

93
1993: 1
94
1994: 20
95
1995: 25
96
1996: 4
97
1997: 49
98
1998: 101
99
1999: 117
00
2000: 271
01
2001: 110
02
2002: 135
03
2003: 145
04
2004: 160
05
2005: 384
06
2006: 247
07
2007: 288
08
2008: 348
09
2009: 355
10
2010: 691
11
2011: 415
12
2012: 544
13
2013: 796
14
2014: 546
15
2015: 562
16
2016: 502
17
2017: 492
18
2018: 341
19
2019: 298
20
2020: 400
21
2021: 591
22
2022: 392
23
2023: 320
24
2024: 419
25
2025: 251
26
2026: 48

Related Entities for Appliance, Fixation, Spinal Intervertebral Body

Event Locations

6,627 (63.9%)
I 2,684 (25.9%)
HOSPITAL 687 (6.6%)
OTHER 141 (1.4%)
NO INFORMATION 94 (0.9%)
HOME 45 (0.4%)
NOT APPLICABLE 40 (0.4%)
INVALID DATA 24 (0.2%)
UNKNOWN 21 (0.2%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
CLINIC - WALK IN, OTHER 1 (0.0%)
PSYCHIATRIC CENTER - WALK IN, OTHER 1 (0.0%)

Compare SYNTHES (USA) vs SYNTHES USA →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Appliance, 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 (10,368 here).

Similar death-typed counts

Nearest other device types by death-typed report count (59 here), distinct from the volume row.

Disclaimer: MAUDE figures for Appliance 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 Appliance; 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.