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 Class II (moderate risk, special controls required), regulated under 21 CFR §864.9245 (Hematology panel).
FDA MAUDE casebook
openFDA event book Platelet And Plasma Separator For Bone Graf… LIGHT-BOOK · MAUDE
#943 of 1000 · 432 reports · 2013–2026
- BOOK 432 reports
- RANK #943 of 1000
- DEATH 0 death-typed
- INJ 71 injury-typed
- MALF 359 malfunction
- SPAN 2013–2026
- PEAK 2024: 117
- PHOTO Stand, Infusion
Nearest event-volume peer: Stand, Infusion (0 report gap)
Platelet And Plasma Separator For Bone Graft Handling sits #943 of 1000 among tracked device types with 432 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 →
Malfunction reports run above the device-type norm
Platelet And Plasma Separator For Bone Graf… carries 83.1% MALFUNCTION-coded reports, 18.3pp 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 16.4% corpus 30.3% · below corpus mean (-13.9 pp)
- MALF 83.1% corpus 64.8% · above corpus mean (+18.3 pp)
Lead product-problem code Defective Device is 17% of coded problems · Lead manufacturer ARTHREX, INC. accounts for 94% of manufacturer-tagged reports · Top event location is 83% 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
- Condenser
Condenser, Heat And Moisture (Artificial Nose)
435 reports
- Arterial Bloo…
Arterial Blood Sampling Kit
433 reports
- Platelet And… (this)
Platelet And Plasma Separator For Bone Graft Handling
432 reports
- Stand
Stand, Infusion
432 reports
- Syringe
Syringe, Periodontic, Endodontic, Irrigating
432 reports
- System
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
431 reports
What this shows Platelet And Plasma Separator For Bone Graft Handling carries 432 MAUDE reports, ranked #943 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (106) held close to the prior two-year average of 100.
Related Entities for Platelet And Plasma Separator For Bone Graft Handling
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Platelet And Plasma Separator For Bone Graf… 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 (432 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
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.