Implant, Endosseous, Root-Form
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 §872.3640 (Dental panel).
FDA MAUDE casebook
openFDA event book Implant, Endosseous, Root-Form HEAVY-BOOK · MAUDE
#1 of 1000 · 3,864,627 reports · 1993–2026
- BOOK 3,864,627 reports
- RANK #1 of 1000
- DEATH 44 death-typed
- INJ 3,833,903 injury-typed
- MALF 29,999 malfunction
- SPAN 1993–2026
- PEAK 2025: 745,835
- PHOTO Integrated Continuous…
Nearest event-volume peer: Integrated Continuous Glucose Monitoring System, Factory Calibrated (1,690,432 report gap)
Implant, Endosseous, Root-Form sits #1 of 1000 among tracked device types with 3,864,627 MAUDE reports spanning 1993–2026. 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
Implant, Endosseous, Root-Form carries 99.2% INJURY-coded reports, 68.9pp 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 99.2% corpus 30.3% · above corpus mean (+68.9 pp)
- MALF 0.8% corpus 64.8% · below corpus mean (-64.1 pp)
Lead product-problem code Failure to Osseointegrate is 63% of coded problems · Lead manufacturer INSTITUT STRAUMANN AG accounts for 40% of manufacturer-tagged reports · Top event location OTHER is 38% of location-tagged rows .
Implant, Endosseous, Root-Form in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Implant (this)
Implant, Endosseous, Root-Form
3,864,627 reports
- Integrated Co…
Integrated Continuous Glucose Monitoring System, Factory Calibrated
2,174,195 reports
- Pump, Infusion
Pump, Infusion
1,827,009 reports
- Alternate Con… 1,260,826
Alternate Controller Enabled Insulin Infusion Pump
1,260,826 reports
- Pump 890,539
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
890,539 reports
- Automated Ins… 885,752
Automated Insulin Dosing Device System, Single Hormonal Control
885,752 reports
What this shows Implant, Endosseous, Root-Form carries 3,864,627 MAUDE reports, ranked #1 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 (745,835) held close to the prior two-year average of 617,344.
Related Entities for Implant, Endosseous, Root-Form
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Implant, Endosseous, Root-Form: 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 (3,864,627 here).
Similar death-typed counts
Nearest other device types by death-typed report count (44 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Implant, Endosseous, Root-Form 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 Implant, Endosseous, Root-Form; 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.