2026 data FDA MAUDE openFDA FDA Class I

Bone Mill

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 §888.4540 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Bone Mill LIGHT-BOOK · MAUDE

#609 of 1000 · 1,273 reports · 2000–2026

  • BOOK 1,273 reports
  • RANK #609 of 1000
  • DEATH 0 death-typed
  • INJ 11 injury-typed
  • MALF 1,260 malfunction
  • SPAN 2000–2026
  • PEAK 2023: 386
  • PHOTO Bed

Nearest event-volume peer: Bed, Pediatric Open Hospital (1 report gap)

Bone Mill sits #609 of 1000 among tracked device types with 1,273 MAUDE reports spanning 2000–2026. 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

Bone Mill carries 99.0% MALFUNCTION-coded reports, 34.2pp 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 0.9% corpus 30.3% · below corpus mean (-29.4 pp)
  • MALF 99.0% corpus 64.8% · above corpus mean (+34.2 pp)

Lead product-problem code Failure to Cut is 76% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 90% of manufacturer-tagged reports · Top event location is 79% of location-tagged rows .

Bone Mill in the event-volume neighbourhood

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

reports

What this shows Bone Mill carries 1,273 MAUDE reports, ranked #609 of 1000.

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

Event Types

Malfunction 1,260 (99.0%)
Injury 11 (0.9%)
Other 2 (0.2%)

Patient Outcomes

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

1,259 (99.1%)
Required Intervention 10 (0.8%)
Other 2 (0.2%)

Top Product Problems

Failure to Cut 1,047
Dull, Blunt 136
Naturally Worn 48
Material Deformation 34
Break 31
Device-Device Incompatibility 15
Illegible Information 14
Material Twisted/Bent 10
Detachment of Device or Device Component 8
Scratched Material 7
Adverse Event Without Identified Device or Use Problem 5
Contamination /Decontamination Problem 5
No Apparent Adverse Event 4
Appropriate Device Problem Term/Code Not Available 3
Improper or Incorrect Procedure or Method 3
Material Integrity Problem 3
Component(s), broken 2
Loose or Intermittent Connection 2
Mechanical Problem 2
Component Missing 1

Yearly Trend

00
2000: 1
01
2001: 1
02
2002: 2
10
2010: 1
11
2011: 1
14
2014: 2
17
2017: 1
18
2018: 46
19
2019: 54
20
2020: 66
21
2021: 173
22
2022: 201
23
2023: 386
24
2024: 305
25
2025: 26
26
2026: 7

Reports fell to 26 in 2025, down from an average of 346 in the two years before.

Related Entities for Bone Mill

Event Locations

1,011 (79.4%)
I 256 (20.1%)
HOSPITAL 4 (0.3%)
NO INFORMATION 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare DEPUY ORTHOPAEDICS INC US vs DEPUY IRELAND - 9616671 →

Nationwide devices with a comparable report-volume footprint

Bone Mill 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 (1,273 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 Bone Mill 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 Bone Mill; 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.