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2026 data FDA MAUDE openFDA FDA Class II

Screw, Fixation, Intraosseous

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 §872.4880 (Dental panel).

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FDA MAUDE casebook

openFDA event book Screw, Fixation, Intraosseous LIGHT-BOOK · MAUDE

#566 of 1000 · 1,522 reports · 1995–2026

  • BOOK 1,522 reports
  • RANK #566 of 1000
  • DEATH 0 death-typed
  • INJ 706 injury-typed
  • MALF 809 malfunction
  • SPAN 1995–2026
  • PEAK 2012: 236
  • PHOTO Confocal Optical Imag…

Nearest event-volume peer: Confocal Optical Imaging (3 report gap)

Screw, Fixation, Intraosseous sits #566 of 1000 among tracked device types with 1,522 MAUDE reports spanning 1995–2026. 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

Screw, Fixation, Intraosseous carries 46.4% INJURY-coded reports, 16.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 46.4% corpus 30.3% · above corpus mean (+16.1 pp)
  • MALF 53.2% corpus 64.8% · below corpus mean (-11.7 pp)

Lead product-problem code Break is 43% of coded problems · Lead manufacturer SYNTHES USA accounts for 29% of manufacturer-tagged reports · Top event location is 73% of location-tagged rows .

Screw, Fixation, Intraosseous in the event-volume neighbourhood

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

reports

What this shows Screw, Fixation, Intraosseous carries 1,522 MAUDE reports, ranked #566 of 1000.

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

Event Types

Malfunction 809 (53.2%)
Injury 706 (46.4%)
Other 5 (0.3%)
2 (0.1%)

Patient Outcomes

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

783 (51.0%)
Required Intervention 559 (36.4%)
Other 168 (10.9%)
R 11 (0.7%)
Hospitalization 10 (0.7%)
O 2 (0.1%)
S 1 (0.1%)
Death 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Break 668
Adverse Event Without Identified Device or Use Problem 204
Fracture 127
Insufficient Device Problem Information 74
Detachment Of Device Component 61
Physical Resistance/Sticking 52
Device Slipped 48
Patient Device Interaction Problem 42
Material Fragmentation 34
Entrapment of Device 33
Device Operates Differently Than Expected 27
Difficult to Insert 27
Mechanical Jam 25
Material Twisted/Bent 22
Difficult to Remove 21
Detachment of Device or Device Component 18
Loose or Intermittent Connection 16
Unintended Movement 16
Manufacturing, Packaging or Shipping Problem 15
Bent 14

Yearly Trend

95
1995: 1
96
1996: 2
97
1997: 3
99
1999: 2
00
2000: 2
03
2003: 1
04
2004: 2
05
2005: 6
06
2006: 3
07
2007: 4
08
2008: 1
09
2009: 8
10
2010: 17
11
2011: 12
12
2012: 236
13
2013: 178
14
2014: 106
15
2015: 103
16
2016: 34
17
2017: 74
18
2018: 57
19
2019: 50
20
2020: 85
21
2021: 55
22
2022: 162
23
2023: 100
24
2024: 106
25
2025: 71
26
2026: 41

Reports in 2025 (71) held close to the prior two-year average of 103.

Related Entities for Screw, Fixation, Intraosseous

Top Manufacturers

SYNTHES USA 312
SYNTHES GMBH 278
SYNTHES (USA) 155
ZIMMER BIOMET, INC. 155
SYNTHES MONUMENT 93
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 59
OBERDORF SYNTHES PRODUKTIONS GMBH 39

Event Locations

1,104 (72.5%)
I 363 (23.9%)
HOSPITAL 47 (3.1%)
NO INFORMATION 2 (0.1%)
UNKNOWN 2 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
HOME 1 (0.1%)
INVALID DATA 1 (0.1%)
OTHER 1 (0.1%)

Compare SYNTHES USA vs SYNTHES GMBH →

Nationwide devices with a comparable report-volume footprint

Screw, Fixation, Intraosseous carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,522 here).

Confocal Optical Imaging 1,525 Laser, Ophthalmic 1,525 Mesh 1,516 Continuous Glucose Monitor 1,514

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Screw, Fixation, Intraosseous 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 Screw, Fixation, Intraosseous; 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.