2026 data FDA MAUDE openFDA FDA Class I

Orthopedic Tray

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).

FDA MAUDE casebook

openFDA event book Orthopedic Tray LIGHT-BOOK · MAUDE

#812 of 1000 · 629 reports · 2012–2026

  • BOOK 629 reports
  • RANK #812 of 1000
  • DEATH 0 death-typed
  • INJ 273 injury-typed
  • MALF 351 malfunction
  • SPAN 2012–2026
  • PEAK 2024: 133
  • PHOTO Charger, Pacemaker

Nearest event-volume peer: Charger, Pacemaker (3 report gap)

Orthopedic Tray sits #812 of 1000 among tracked device types with 629 MAUDE reports spanning 2012–2026. 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

Orthopedic Tray carries 43.4% INJURY-coded reports, 13.1pp 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 43.4% corpus 30.3% · above corpus mean (+13.1 pp)
  • MALF 55.8% corpus 64.8% · below corpus mean (-9.0 pp)

Lead product-problem code Break is 17% of coded problems · Lead manufacturer MEDLINE INDUSTRIES, LP accounts for 61% of manufacturer-tagged reports · Top event location is 52% of location-tagged rows .

Orthopedic Tray in the event-volume neighbourhood

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

reports

What this shows Orthopedic Tray carries 629 MAUDE reports, ranked #812 of 1000.

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

Event Types

Malfunction 351 (55.8%)
Injury 273 (43.4%)
3 (0.5%)
No answer provided 1 (0.2%)
Other 1 (0.2%)

Patient Outcomes

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

Other 310 (50.1%)
208 (33.6%)
Required Intervention 80 (12.9%)
Hospitalization 9 (1.5%)
R 8 (1.3%)
H 2 (0.3%)
S 2 (0.3%)

Top Product Problems

Break 81
Adverse Event Without Identified Device or Use Problem 67
Appropriate Device Problem Term/Code Not Available 57
Material Integrity Problem 41
Contamination 39
Contamination /Decontamination Problem 24
Fracture 17
Insufficient Device Problem Information 17
Component Missing 15
Material Fragmentation 15
No Apparent Adverse Event 15
Device Contamination with Chemical or Other Material 13
Use of Device Problem 13
Material Separation 12
Leak/Splash 11
Detachment of Device or Device Component 10
Delivered as Unsterile Product 9
Adhesive Too Strong 8
Device Operates Differently Than Expected 8
Material Split, Cut or Torn 8

Yearly Trend

12
2012: 2
15
2015: 2
16
2016: 1
17
2017: 16
18
2018: 59
19
2019: 78
20
2020: 38
21
2021: 40
22
2022: 27
23
2023: 44
24
2024: 133
25
2025: 85
26
2026: 104

Reports in 2025 (85) held close to the prior two-year average of 89.

Related Entities for Orthopedic Tray

Event Locations

325 (51.7%)
HOSPITAL 165 (26.2%)
I 103 (16.4%)
NO INFORMATION 22 (3.5%)
AMBULATORY SURGICAL FACILITY 8 (1.3%)
OTHER 3 (0.5%)
OUTPATIENT TREATMENT FACILITY 2 (0.3%)
HOME 1 (0.2%)

Compare MEDLINE INDUSTRIES, LP vs MEDLINE INDUSTRIES LP →

Nationwide devices with a comparable report-volume footprint

Orthopedic Tray 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 (629 here).

Similar death-typed counts

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

Disclaimer: MAUDE figures for Orthopedic Tray 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 Orthopedic Tray; 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.