infinity OCTAGON 503310Recalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Tissue Level Implant Regular Platform Ø3,3x10 · Class 2 · Implant
All models of infinity OCTAGON (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Hager & Meisinger infinity dental implant appears in 92 adverse event reports, with no deaths and 91 injuries. Reports mostly describe implants failing to fuse with the bone or losing that fusion over time, and some describe implant fractures. There were no reports in the past 12 months, down from 33 in the year before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 92
- Deaths reported
- 0
- Injuries reported
- 91
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI E0HM5033101), received between Nov 16, 2020 and Mar 24, 2025 — classified as 91 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (53 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate53
- Loss of Osseointegration21
- Patient Device Interaction Problem9
- Osseointegration Problem6
- Fracture5
- Material Integrity Problem1
Patient problems
- Failure of Implant53
- Inadequate Osseointegration39
Recent adverse event reports
The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2025Fracture; Fracture
InjuryMar 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
MISSING OSSEOINTEGRATION (3 IMPLANTS AT SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 21639942 ↗InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
MISSING OSSEOINTEGRATION (2 IMPLANTS AT SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 21639940 ↗InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
MISSING OSSEOINTEGRATION (2 IMPLANTS AT SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 21639938 ↗InjuryMar 18, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 18, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 18, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 18, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 18, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
AT 2-1/2 MONTH CHECK THE IMPLANT WAS LOOSE.
Patient problems: Failure of Implant
MAUDE report 21172693 ↗InjuryJan 9, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 9, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 9, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF OSSEOINTEGRATION. IMPLANT WAS MOBILE.
Patient problems: Failure of Implant
MAUDE report 21107369 ↗InjuryJan 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF OSSEOINTEGRATION. IMPLANT WAS MOBILE.
Patient problems: Failure of Implant
MAUDE report 21107368 ↗InjuryJan 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF OSSEOINTEGRATION. IMPLANT WAS MOBILE.
Patient problems: Failure of Implant
MAUDE report 21107367 ↗InjuryJan 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF OSSEOINTEGRATION. IMPLANT WAS MOBILE.
Patient problems: Failure of Implant
MAUDE report 21107366 ↗
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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