2026 data FDA MAUDE openFDA

Guide, Surgical, Instrument

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 Guide, Surgical, Instrument LIGHT-BOOK · MAUDE

#236 of 1000 · 8,257 reports · 1996–2026

  • BOOK 8,257 reports
  • RANK #236 of 1000
  • DEATH 4 death-typed
  • INJ 1,463 injury-typed
  • MALF 6,776 malfunction
  • SPAN 1996–2026
  • PEAK 2024: 882
  • PHOTO Stent, Carotid

Nearest event-volume peer: Stent, Carotid (82 report gap)

Guide, Surgical, Instrument sits #236 of 1000 among tracked device types with 8,257 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 17.7% corpus 30.4% · below corpus mean (-12.7 pp)
  • MALF 82.1% corpus 64.5% · above corpus mean (+17.6 pp)

Lead product-problem code Device-Device Incompatibility is 32% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 41% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .

Guide, Surgical, Instrument in the event-volume neighbourhood

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

reports

What this shows Guide, Surgical, Instrument carries 8,257 MAUDE reports, ranked #236 of 1000.

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

Event Types

Malfunction 6,776 (82.1%)
Injury 1,463 (17.7%)
7 (0.1%)
Other 7 (0.1%)
Death 4 (0.0%)

Patient Outcomes

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

6,677 (79.1%)
Required Intervention 1,202 (14.2%)
Other 282 (3.3%)
R 115 (1.4%)
Hospitalization 76 (0.9%)
O 60 (0.7%)
H 16 (0.2%)
Death 4 (0.0%)
Disability 4 (0.0%)
Life Threatening 2 (0.0%)
D 1 (0.0%)
L 1 (0.0%)
S 1 (0.0%)

Top Product Problems

Device-Device Incompatibility 2,171
Break 1,488
Adverse Event Without Identified Device or Use Problem 621
Material Deformation 513
Material Twisted/Bent 353
Fracture 249
Failure to Align 203
Mechanical Jam 185
Unstable 161
Fitting Problem 129
Device Operates Differently Than Expected 126
Device Contaminated During Manufacture or Shipping 97
Entrapment of Device 83
Use of Device Problem 83
Material Integrity Problem 80
Detachment of Device or Device Component 62
Bent 59
Material Fragmentation 45
Packaging Problem 43
Crack 37

Yearly Trend

96
1996: 2
97
1997: 1
98
1998: 6
99
1999: 7
00
2000: 4
01
2001: 6
02
2002: 11
03
2003: 5
04
2004: 3
05
2005: 2
06
2006: 1
07
2007: 5
08
2008: 6
09
2009: 10
10
2010: 41
11
2011: 27
12
2012: 39
13
2013: 725
14
2014: 524
15
2015: 452
16
2016: 467
17
2017: 368
18
2018: 447
19
2019: 535
20
2020: 734
21
2021: 795
22
2022: 581
23
2023: 837
24
2024: 882
25
2025: 632
26
2026: 102

Related Entities for Guide, Surgical, Instrument

Event Locations

4,855 (58.8%)
I 3,308 (40.1%)
HOSPITAL 83 (1.0%)
NO INFORMATION 8 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
INVALID DATA 1 (0.0%)
OTHER 1 (0.0%)

Compare SYNTHES GMBH vs WRIGHTS LANE SYNTHES USA PRODUCTS LLC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Guide, Surgical, Instrument, 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 (8,257 here).

Similar death-typed counts

Nearest other device types by death-typed report count (4 here), distinct from the volume row.

Disclaimer: MAUDE figures for Guide, Surgical, Instrument 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 Guide, Surgical, Instrument; 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.