Staple, Fixation, Bone
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 §888.3030 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Staple, Fixation, Bone LIGHT-BOOK · MAUDE
#438 of 1000 · 2,647 reports · 1994–2026
- BOOK 2,647 reports
- RANK #438 of 1000
- DEATH 0 death-typed
- INJ 1,354 injury-typed
- MALF 1,282 malfunction
- SPAN 1994–2026
- PEAK 2025: 318
- PHOTO System
Nearest event-volume peer: System, Imaging, Pulsed Doppler, Ultrasonic (12 report gap)
Staple, Fixation, Bone sits #438 of 1000 among tracked device types with 2,647 MAUDE reports spanning 1994–2026. 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
Staple, Fixation, Bone carries 51.2% INJURY-coded reports, 20.9pp 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 51.2% corpus 30.3% · above corpus mean (+20.9 pp)
- MALF 48.4% corpus 64.8% · below corpus mean (-16.4 pp)
Lead product-problem code Break is 32% of coded problems · Lead manufacturer DEPUY MITEK LLC US accounts for 24% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .
Staple, Fixation, Bone in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Intraocular P…
Intraocular Pressure Lowering Implant
2,671 reports
- System
System, Imaging, Pulsed Doppler, Ultrasonic
2,659 reports
- Staple (this)
Staple, Fixation, Bone
2,647 reports
- Handpiece
Handpiece, Contra- And Right-Angle Attachment, Dental
2,629 reports
- Device
Device, Anti-Snoring
2,628 reports
- Prosthesis
Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
2,621 reports
What this shows Staple, Fixation, Bone carries 2,647 MAUDE reports, ranked #438 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 rose to 318 in 2025, up from an average of 191 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Staple, Fixation, Bone
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Staple, Fixation, Bone 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 (2,647 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 Staple, Fixation, Bone 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 Staple, Fixation, Bone; 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.