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2026 data FDA MAUDE openFDA

Screw, Fixation, Bone

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.

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FDA MAUDE casebook

openFDA event book Screw, Fixation, Bone MID-BOOK · MAUDE

#60 of 1000 · 56,966 reports · 1992–2026

  • BOOK 56,966 reports
  • RANK #60 of 1000
  • DEATH 76 death-typed
  • INJ 38,603 injury-typed
  • MALF 17,205 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 5,464
  • PHOTO Implantable Pacemaker…

Nearest event-volume peer: Implantable Pacemaker Pulse-Generator (377 report gap)

Screw, Fixation, Bone sits #60 of 1000 among tracked device types with 56,966 MAUDE reports spanning 1992–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 67.8% corpus 30.4% · above corpus mean (+37.3 pp)
  • MALF 30.2% corpus 64.5% · below corpus mean (-34.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 40% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 26% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Screw, Fixation, Bone in the event-volume neighbourhood

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

reports

What this shows Screw, Fixation, Bone carries 56,966 MAUDE reports, ranked #60 of 1000.

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

Event Types

Injury 38,603 (67.8%)
Malfunction 17,205 (30.2%)
Other 851 (1.5%)
231 (0.4%)
Death 76 (0.1%)

Patient Outcomes

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

Required Intervention 32,415 (54.3%)
16,522 (27.7%)
Other 5,607 (9.4%)
Hospitalization 2,198 (3.7%)
R 2,152 (3.6%)
O 255 (0.4%)
H 211 (0.4%)
S 139 (0.2%)
Death 85 (0.1%)
Disability 73 (0.1%)
L 17 (0.0%)
Life Threatening 13 (0.0%)
Congenital Anomaly 4 (0.0%)
D 3 (0.0%)
Invalid Data 2 (0.0%)
C 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 14,840
Break 8,995
Migration 2,463
Device-Device Incompatibility 2,258
Fracture 1,453
Material Twisted/Bent 760
Insufficient Information 700
Entrapment of Device 569
No Apparent Adverse Event 529
Migration or Expulsion of Device 496
Material Fragmentation 488
Device Slipped 477
Device Dislodged or Dislocated 453
Unintended Movement 433
Appropriate Term/Code Not Available 375
Patient Device Interaction Problem 352
Material Deformation 322
Positioning Failure 315
Detachment of Device or Device Component 282
Loosening of Implant Not Related to Bone-Ingrowth 271

Yearly Trend

92
1992: 21
93
1993: 23
94
1994: 52
95
1995: 25
96
1996: 55
97
1997: 161
98
1998: 151
99
1999: 126
00
2000: 140
01
2001: 211
02
2002: 281
03
2003: 236
04
2004: 240
05
2005: 432
06
2006: 652
07
2007: 669
08
2008: 660
09
2009: 651
10
2010: 765
11
2011: 1,105
12
2012: 3,340
13
2013: 3,850
14
2014: 2,548
15
2015: 2,711
16
2016: 2,285
17
2017: 2,561
18
2018: 3,662
19
2019: 5,464
20
2020: 4,820
21
2021: 4,446
22
2022: 3,934
23
2023: 3,718
24
2024: 3,575
25
2025: 2,932
26
2026: 464

Related Entities for Screw, Fixation, Bone

Top Manufacturers

SYNTHES GMBH 9,572
SYNTHES USA 6,502
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6,223
OBERDORF SYNTHES PRODUKTIONS GMBH 3,633
SYNTHES (USA) 3,137
STRYKER GMBH 2,316
SMITH & NEPHEW, INC. 1,771
ARTHREX, INC. 1,725
DEPUY MITEK LLC US 1,376
ZIMMER BIOMET, INC. 1,102

Event Locations

30,366 (53.3%)
I 23,113 (40.6%)
HOSPITAL 2,627 (4.6%)
AMBULATORY SURGICAL FACILITY 271 (0.5%)
OTHER 205 (0.4%)
NO INFORMATION 157 (0.3%)
INVALID DATA 67 (0.1%)
UNKNOWN 53 (0.1%)
HOME 45 (0.1%)
NOT APPLICABLE 30 (0.1%)
OUTPATIENT TREATMENT FACILITY 16 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 10 (0.0%)
NURSING HOME 4 (0.0%)
AMBULATORY SURGICAL CENTER 2 (0.0%)

Compare SYNTHES GMBH vs SYNTHES USA →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Screw, Fixation, Bone, 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 (56,966 here).

Implantable Pacemaker Pulse-Generator 57,343 Gastroscope And Accessories, Flexible/Rigid 56,447 Endoscopic Video Imaging System/Component 53,347 Suture 52,543

Similar death-typed counts

Nearest other device types by death-typed report count (76 here), distinct from the volume row.

Clamp, Vascular 76 Monitor, Bed Patient 76 Stimulator, Autonomic Nerve, Implanted 76 Lift, Patient, Ac-Powered 75

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

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