infinity OCTAGON 504110Recalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Tissue Level Implant Regular Platform Ø4,1x10 · Class 2 · Implant
Quick summary
This Infinity OCTAGON dental implant has 98 adverse event reports. They mostly describe the implant failing to integrate with bone or losing that integration, and mention 97 injuries and no deaths. There are no recalls for this device. Reports dropped from 25 in the prior 12 months to 0 in the most recent 12 months.
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
- 98
- Deaths reported
- 0
- Injuries reported
- 97
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI E0HM5041101), received between Mar 13, 2019 and Mar 24, 2025 — classified as 97 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (48 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate48
- Loss of Osseointegration19
- Osseointegration Problem18
- Patient Device Interaction Problem15
- Loosening of Implant Not Related to Bone-Ingrowth3
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant59
- Inadequate Osseointegration39
- Numbness2
- Pain2
- Swelling/ Edema2
Recent adverse event reports
The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 24, 2025Loss of Osseointegration; Loss of Osseointegration
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
InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF OSSEOINTEGRATION. IMPLANT WAS MOBILE.
Patient problems: Failure of Implant
MAUDE report 21098059 ↗InjuryJan 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF OSSEOINTEGRATION. IMPLANT WAS MOBILE.
Patient problems: Failure of Implant
MAUDE report 21097772 ↗InjuryJan 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF OSSEOINTEGRATION. IMPLANT WAS MOBILE.
Patient problems: Failure of Implant
MAUDE report 21097770 ↗InjuryJan 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.