PlainHospital
2024 data FDA MAUDE openFDA FDA Class II

Implant, Fixation Device, Spinal

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 Class II (moderate risk, special controls required), regulated under 21 CFR §888.3060 (Orthopedic panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Implant, Fixation Device, Spinal LIGHT-BOOK · MAUDE

#689 of 1000 · 909 reports · 1992–2024

  • BOOK 909 reports
  • RANK #689 of 1000
  • DEATH 6 death-typed
  • INJ 616 injury-typed
  • MALF 205 malfunction
  • SPAN 1992–2024
  • PEAK 1997: 105
  • PHOTO Device

Nearest event-volume peer: Device, Incontinence, Urosheath Type, Non-Sterile (0 report gap)

Implant, Fixation Device, Spinal sits #689 of 1000 among tracked device types with 909 MAUDE reports spanning 1992–2024. 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 →

Malfunction reports sit below the device-type norm

Implant, Fixation Device, Spinal carries 22.6% MALFUNCTION-coded reports, 42.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 67.8% corpus 30.3% · above corpus mean (+37.5 pp)
  • MALF 22.6% corpus 64.8% · below corpus mean (-42.3 pp)

Lead product-problem code Explanted is 23% of coded problems · Lead manufacturer SYNTHES (USA) accounts for 33% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Implant, Fixation Device, Spinal in the event-volume neighbourhood

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

reports

What this shows Implant, Fixation Device, Spinal carries 909 MAUDE reports, ranked #689 of 1000.

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

Event Types

Injury 616 (67.8%)
Malfunction 205 (22.6%)
Other 66 (7.3%)
16 (1.8%)
Death 6 (0.7%)

Patient Outcomes

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

Required Intervention 444 (42.6%)
195 (18.7%)
Hospitalization 133 (12.8%)
Other 98 (9.4%)
R 85 (8.2%)
Disability 28 (2.7%)
S 25 (2.4%)
O 11 (1.1%)
L 9 (0.9%)
Death 5 (0.5%)
Life Threatening 3 (0.3%)
H 2 (0.2%)
Congenital Anomaly 2 (0.2%)
D 1 (0.1%)
Not Applicable 1 (0.1%)

Top Product Problems

Explanted 269
Break 217
Replace 112
Device remains implanted 86
Fracture 74
Loose 64
Unknown (for use when the device problem is not known) 54
Insufficient Device Problem Information 43
Component(s), broken 36
Implant, removal of 36
Migration or Expulsion of Device 27
Material Separation 25
Device Slipped 24
Dislodged 23
Adverse Event Without Identified Device or Use Problem 18
Other (for use when an appropriate device code cannot be identified) 18
Device Issue 17
Detachment Of Device Component 15
Implant breakage or physical damage 12
Device Operates Differently Than Expected 11

Yearly Trend

92
1992: 3
93
1993: 5
94
1994: 14
95
1995: 62
96
1996: 53
97
1997: 105
98
1998: 58
99
1999: 44
00
2000: 50
01
2001: 11
02
2002: 5
03
2003: 18
04
2004: 26
05
2005: 25
06
2006: 78
07
2007: 77
08
2008: 50
09
2009: 56
10
2010: 5
11
2011: 3
12
2012: 8
13
2013: 64
14
2014: 17
15
2015: 23
16
2016: 2
17
2017: 6
18
2018: 2
19
2019: 6
20
2020: 6
21
2021: 2
22
2022: 16
23
2023: 8
24
2024: 1

Reports in 2023 (8) held close to the prior two-year average of 9.

Related Entities for Implant, Fixation Device, Spinal

Top Manufacturers

SYNTHES (USA) 64
SYNTHES USA 50
DEPUY SPINE, INC. 45
UNKNOWN 33

Event Locations

595 (65.5%)
HOSPITAL 143 (15.7%)
NOT APPLICABLE 47 (5.2%)
INVALID DATA 38 (4.2%)
I 30 (3.3%)
HOME 27 (3.0%)
UNKNOWN 15 (1.7%)
NO INFORMATION 9 (1.0%)
OTHER 4 (0.4%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)

Compare SYNTHES (USA) vs SYNTHES USA →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Implant, Fixation Device, Spinal: 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 (909 here).

Device 909 Appliance 910 Passer 906 Enzyme Immunoassay, Diphenylhydantoin 905

Similar death-typed counts

Nearest other device types by death-typed report count (6 here), distinct from the volume row.

Applicator, Absorbent Tipped, Non-Sterile 6 Cable, Electrode 6 Catheter, Straight 6 Dilator, Catheter, Ureteral 6

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

Disclaimer: MAUDE figures for Implant, Fixation Device, Spinal 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 Implant, Fixation Device, Spinal; 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.