Orthopedic Stereotaxic Instrument
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 §882.4560 (Neurology panel).
FDA MAUDE casebook
openFDA event book Orthopedic Stereotaxic Instrument MID-BOOK · MAUDE
#138 of 1000 · 20,328 reports · 2008–2026
- BOOK 20,328 reports
- RANK #138 of 1000
- DEATH 13 death-typed
- INJ 3,735 injury-typed
- MALF 16,561 malfunction
- SPAN 2008–2026
- PEAK 2025: 3,344
- PHOTO Reagents
Nearest event-volume peer: Reagents, 2019-Novel Coronavirus Nucleic Acid (186 report gap)
Orthopedic Stereotaxic Instrument sits #138 of 1000 among tracked device types with 20,328 MAUDE reports spanning 2008–2026. 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
Orthopedic Stereotaxic Instrument carries 81.5% MALFUNCTION-coded reports, 16.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 18.4% corpus 30.3% · below corpus mean (-11.9 pp)
- MALF 81.5% corpus 64.8% · above corpus mean (+16.6 pp)
Lead product-problem code Break is 12% of coded problems · Lead manufacturer MAKO SURGICAL CORP. accounts for 31% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .
Orthopedic Stereotaxic Instrument in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- General Surge…
General Surgery Tray
20,596 reports
- Orthopedic St… (this)
Orthopedic Stereotaxic Instrument
20,328 reports
- Reagents
Reagents, 2019-Novel Coronavirus Nucleic Acid
20,142 reports
- Catheter
Catheter, Intravascular, Diagnostic
20,128 reports
- Suture
Suture, Nonabsorbable, Synthetic, Polyethylene
20,010 reports
- Leadless Pace…
Leadless Pacemaker
19,964 reports
What this shows Orthopedic Stereotaxic Instrument carries 20,328 MAUDE reports, ranked #138 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 3,344 in 2025, up from an average of 1,924 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Orthopedic Stereotaxic Instrument
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Orthopedic Stereotaxic Instrument: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (20,328 here).
Similar death-typed counts
Nearest other device types by death-typed report count (13 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Orthopedic Stereotaxic Instrument 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 Orthopedic Stereotaxic Instrument; 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.