2026 data FDA MAUDE openFDA

Orthosis, Spondylolisthesis Spinal Fixation

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 Orthosis, Spondylolisthesis Spinal Fixation LIGHT-BOOK · MAUDE

#336 of 1000 · 4,362 reports · 1996–2026

  • BOOK 4,362 reports
  • RANK #336 of 1000
  • DEATH 2 death-typed
  • INJ 2,803 injury-typed
  • MALF 1,525 malfunction
  • SPAN 1996–2026
  • PEAK 2021: 531
  • PHOTO Broach

Nearest event-volume peer: Broach (56 report gap)

Orthosis, Spondylolisthesis Spinal Fixation sits #336 of 1000 among tracked device types with 4,362 MAUDE reports spanning 1996–2026. 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 64.3% corpus 30.4% · above corpus mean (+33.8 pp)
  • MALF 35.0% corpus 64.5% · below corpus mean (-29.5 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 32% of coded problems · Lead manufacturer OBERDORF SYNTHES PRODUKTIONS GMBH accounts for 21% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Orthosis, Spondylolisthesis Spinal Fixation in the event-volume neighbourhood

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

reports

What this shows Orthosis, Spondylolisthesis Spinal Fixation carries 4,362 MAUDE reports, ranked #336 of 1000.

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

Event Types

Injury 2,803 (64.3%)
Malfunction 1,525 (35.0%)
Other 27 (0.6%)
5 (0.1%)
Death 2 (0.0%)

Patient Outcomes

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

Required Intervention 2,415 (51.3%)
1,034 (22.0%)
Other 664 (14.1%)
R 237 (5.0%)
Hospitalization 213 (4.5%)
O 49 (1.0%)
H 48 (1.0%)
Death 19 (0.4%)
Disability 16 (0.3%)
S 9 (0.2%)
L 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 881
Break 365
Migration 183
Loose or Intermittent Connection 134
Device Slipped 131
No Apparent Adverse Event 130
Fracture 114
Material Integrity Problem 81
Unintended Movement 80
Insufficient Information 79
Mechanical Problem 79
Migration or Expulsion of Device 76
Device Dislodged or Dislocated 67
Material Deformation 66
Device-Device Incompatibility 58
Detachment of Device or Device Component 57
Appropriate Term/Code Not Available 56
Patient Device Interaction Problem 48
Loosening of Implant Not Related to Bone-Ingrowth 42
Material Twisted/Bent 39

Yearly Trend

96
1996: 1
97
1997: 1
98
1998: 1
99
1999: 10
00
2000: 10
01
2001: 6
02
2002: 11
03
2003: 13
04
2004: 9
05
2005: 11
06
2006: 8
07
2007: 18
08
2008: 30
09
2009: 45
10
2010: 59
11
2011: 107
12
2012: 433
13
2013: 464
14
2014: 286
15
2015: 152
16
2016: 216
17
2017: 174
18
2018: 129
19
2019: 403
20
2020: 432
21
2021: 531
22
2022: 265
23
2023: 121
24
2024: 300
25
2025: 91
26
2026: 25

Related Entities for Orthosis, Spondylolisthesis Spinal Fixation

Event Locations

2,407 (55.2%)
I 1,871 (42.9%)
HOSPITAL 58 (1.3%)
NO INFORMATION 15 (0.3%)
HOME 5 (0.1%)
NOT APPLICABLE 3 (0.1%)
UNKNOWN 2 (0.0%)
INVALID DATA 1 (0.0%)

Compare OBERDORF SYNTHES PRODUKTIONS GMBH vs SYNTHES GMBH →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Orthosis, Spondylolisthesis Spinal Fixation, 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 (4,362 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Orthosis, Spondylolisthesis Spinal Fixation 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 Orthosis, Spondylolisthesis Spinal Fixation; 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.