Osteotome
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 Osteotome LIGHT-BOOK · MAUDE
#762 of 1000 · 749 reports · 1992–2026
- BOOK 749 reports
- RANK #762 of 1000
- DEATH 0 death-typed
- INJ 29 injury-typed
- MALF 715 malfunction
- SPAN 1992–2026
- PEAK 2024: 93
- PHOTO Device
Nearest event-volume peer: Device, Intravascular Catheter Securement (0 report gap)
Osteotome sits #762 of 1000 among tracked device types with 749 MAUDE reports spanning 1992–2026. 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
Osteotome carries 95.5% MALFUNCTION-coded reports, 30.6pp 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 3.9% corpus 30.3% · below corpus mean (-26.4 pp)
- MALF 95.5% corpus 64.8% · above corpus mean (+30.6 pp)
Lead product-problem code Break is 46% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 64% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .
Osteotome in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Catheter
Catheter, Balloon, Transcervical
753 reports
- Catheter
Catheter, Balloon Type
751 reports
- Extractor
Extractor, Vacuum, Fetal
751 reports
- Osteotome (this)
Osteotome
749 reports
- Device
Device, Intravascular Catheter Securement
749 reports
- Implanted Bra…
Implanted Brain Stimulator For Epilepsy
746 reports
What this shows Osteotome carries 749 MAUDE reports, ranked #762 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 (54) held close to the prior two-year average of 83.
Related Entities for Osteotome
Top Manufacturers
Event Locations
Compare DEPUY ORTHOPAEDICS INC US vs DEPUY ORTHOPAEDICS, INC. 1818910 →
Nationwide devices with a comparable report-volume footprint
Osteotome 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 (749 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 Osteotome 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 Osteotome; 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.