2026 data FDA MAUDE openFDA

Platelet And Plasma Separator For Bone Graft Handling

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 Platelet And Plasma Separator For Bone Graf… LIGHT-BOOK · MAUDE

#935 of 1000 · 416 reports · 2013–2026

  • BOOK 416 reports
  • RANK #935 of 1000
  • DEATH 0 death-typed
  • INJ 71 injury-typed
  • MALF 343 malfunction
  • SPAN 2013–2026
  • PEAK 2024: 117
  • PHOTO Drug-Eluting Percutan…

Nearest event-volume peer: Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter (1 report gap)

Platelet And Plasma Separator For Bone Graft Handling sits #935 of 1000 among tracked device types with 416 MAUDE reports spanning 2013–2026. 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 17.1% corpus 30.4% · below corpus mean (-13.4 pp)
  • MALF 82.5% corpus 64.5% · above corpus mean (+17.9 pp)

Lead product-problem code Defective Device is 17% of coded problems · Lead manufacturer ARTHREX, INC. accounts for 95% of manufacturer-tagged reports · Top event location is 82% of location-tagged rows .

Platelet And Plasma Separator For Bone Graf… in the event-volume neighbourhood

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

reports

What this shows Platelet And Plasma Separator For Bone Graft Handling carries 416 MAUDE reports, ranked #935 of 1000.

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

Event Types

Malfunction 343 (82.5%)
Injury 71 (17.1%)
2 (0.5%)

Patient Outcomes

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

321 (76.4%)
Other 88 (21.0%)
R 4 (1.0%)
Required Intervention 4 (1.0%)
Hospitalization 3 (0.7%)

Top Product Problems

Defective Device 58
Fluid/Blood Leak 48
Use of Device Problem 41
Leak/Splash 29
Output Problem 24
Material Puncture/Hole 23
Break 21
Device Emits Odor 16
No Flow 16
Separation Failure 10
Patient Device Interaction Problem 8
Physical Resistance/Sticking 8
Insufficient Flow or Under Infusion 7
Positioning Failure 7
Activation Failure 6
Display or Visual Feedback Problem 6
Off-Label Use 6
Smoking 6
Device Expiration Issue 5
Fitting Problem 5

Yearly Trend

13
2013: 1
14
2014: 1
15
2015: 2
16
2016: 6
17
2017: 3
18
2018: 10
19
2019: 11
20
2020: 20
21
2021: 25
22
2022: 25
23
2023: 83
24
2024: 117
25
2025: 106
26
2026: 6

Related Entities for Platelet And Plasma Separator For Bone Graft Handling

Top Manufacturers

Event Locations

343 (82.5%)
I 65 (15.6%)
NO INFORMATION 5 (1.2%)
HOSPITAL 1 (0.2%)
OTHER 1 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Compare ARTHREX, INC. vs TERUMO BCT →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Platelet And Plasma Separator For Bone Graf…, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Disclaimer: MAUDE figures for Platelet And Plasma Separator For Bone Graf… 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 Platelet And Plasma Separator For Bone Graf…; 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.