infinity OCTAGON 503308Recalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Tissue Level Implant Regular Platform Ø3,3x8 · Class 2 · Implant
Quick summary
This infinity OCTAGON dental implant is placed in the jaw to replace a tooth root. The 24 reports mainly describe the implant failing to bond with bone, coming loose, or breaking. There were 24 injuries and no deaths; no recalls name this device. Reports fell from 2 in the previous 12 months to 0 in the latest 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
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI E0HM5033081), received between Mar 22, 2023 and Dec 11, 2024 — classified as 24 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (8 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 Osseointegrate8
- Loss of Osseointegration7
- Patient Device Interaction Problem6
- Fracture2
- Osseointegration Problem1
Patient problems
- Failure of Implant17
- Inadequate Osseointegration7
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 11, 2024Fracture; Fracture
InjurySep 9, 2024Loss of Osseointegration; Loss of Osseointegration
InjurySep 9, 2024Fracture; Fracture
InjuryJun 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 9, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryApr 5, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryApr 5, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryApr 5, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 13, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT & CROWN LOOSE. NO OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18698099 ↗InjuryOct 31, 2023Osseointegration Problem; Osseointegration Problem
InjurySep 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 10, 2023Failure to Osseointegrate; Failure to Osseointegrate
SWELLING AND PUS STARTED TO APPEAR AROUND THE IMPLANT AFTER A FEW WEEKS.
Patient problems: Failure of Implant
MAUDE report 17716964 ↗InjuryMar 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMar 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT WAS A SMOKER. IMPLANT DID NOT OSTEOINTERGRATE.
Patient problems: Failure of Implant
MAUDE report 16598127 ↗InjuryMar 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMar 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMar 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMar 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT WAS A SMOKER - FAILED TO OSTEOINTERGRATE
Patient problems: Failure of Implant
MAUDE report 16593047 ↗
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.