PlainHospital
2026 data FDA MAUDE openFDA FDA Class I

Tray, Surgical

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4800 (General, Plastic Surgery panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Tray, Surgical LIGHT-BOOK · MAUDE

#928 of 1000 · 452 reports · 1993–2026

  • BOOK 452 reports
  • RANK #928 of 1000
  • DEATH 1 death-typed
  • INJ 53 injury-typed
  • MALF 330 malfunction
  • SPAN 1993–2026
  • PEAK 2013: 50
  • PHOTO Blood Grouping Reagent

Nearest event-volume peer: Blood Grouping Reagent (1 report gap)

Tray, Surgical sits #928 of 1000 among tracked device types with 452 MAUDE reports spanning 1993–2026. 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 sit below the device-type norm

Tray, Surgical carries 11.7% INJURY-coded reports, 18.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 11.7% corpus 30.3% · below corpus mean (-18.6 pp)
  • MALF 73.0% corpus 64.8% · above corpus mean (+8.2 pp)

Lead product-problem code Break is 14% of coded problems · Lead manufacturer THE ANSPACH EFFORT, INC. accounts for 51% of manufacturer-tagged reports · Top event location HOSPITAL is 49% of location-tagged rows .

Tray, Surgical in the event-volume neighbourhood

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

reports

What this shows Tray, Surgical carries 452 MAUDE reports, ranked #928 of 1000.

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

Event Types

Malfunction 330 (73.0%)
Injury 53 (11.7%)
Other 37 (8.2%)
30 (6.6%)
Death 1 (0.2%)
No answer provided 1 (0.2%)

Patient Outcomes

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

275 (59.8%)
Other 137 (29.8%)
Required Intervention 34 (7.4%)
R 6 (1.3%)
Hospitalization 3 (0.7%)
O 2 (0.4%)
Death 1 (0.2%)
Disability 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Break 48
Device Contamination with Chemical or Other Material 38
Foreign material 33
Device Packaging Compromised 30
Packaging Problem 25
Detachment Of Device Component 21
Out-Of-Box Failure 17
Replace 16
Disconnection 15
Material Separation 14
Component Missing 11
Appropriate Device Problem Term/Code Not Available 10
Sterility 10
Unknown (for use when the device problem is not known) 10
Device Contaminated During Manufacture or Shipping 8
Device, or device fragments remain in patient 7
Disassembly 7
Hole In Material 7
Crack 6
Delivered as Unsterile Product 6

Yearly Trend

93
1993: 1
94
1994: 4
95
1995: 1
96
1996: 15
97
1997: 23
98
1998: 3
99
1999: 9
00
2000: 24
01
2001: 9
02
2002: 9
03
2003: 11
04
2004: 12
05
2005: 8
06
2006: 37
07
2007: 21
08
2008: 13
09
2009: 16
10
2010: 25
11
2011: 20
12
2012: 10
13
2013: 50
14
2014: 6
15
2015: 15
16
2016: 8
17
2017: 20
18
2018: 8
19
2019: 6
20
2020: 5
21
2021: 3
22
2022: 10
23
2023: 8
24
2024: 20
25
2025: 13
26
2026: 9

Reports in 2025 (13) held close to the prior two-year average of 14.

Related Entities for Tray, Surgical

Top Manufacturers

THE ANSPACH EFFORT, INC. 43
CARDINAL HEALTH 41

Event Locations

HOSPITAL 222 (49.1%)
155 (34.3%)
INVALID DATA 21 (4.6%)
NO INFORMATION 21 (4.6%)
I 12 (2.7%)
OTHER 7 (1.5%)
UNKNOWN 6 (1.3%)
AMBULATORY SURGICAL FACILITY 3 (0.7%)
HOME 2 (0.4%)
NOT APPLICABLE 1 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Compare THE ANSPACH EFFORT, INC. vs CARDINAL HEALTH →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Tray, Surgical: 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 (452 here).

Blood Grouping Reagent 451 Catheter, Recording, Electrode, Reprocessed 449 Dispenser, Cement 456 Orthosis, Limb Brace 456

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Tray, Surgical 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 Tray, Surgical; 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.