infinity OCTAGON 504108Recalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Tissue Level Implant Regular Platform Ø4,1x8 · Class 2 · Implant
Quick summary
This is a small-diameter dental implant made by Hager & Meisinger, used as a root-shaped screw that replaces a missing tooth. The 29 reports mostly describe the implant failing to bond with the surrounding jawbone, so it loosens or is lost, along with pain; 29 injuries and no deaths were reported. No recalls name this device, and no reports came in the past 12 months compared with 2 in the prior12 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
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI E0HM5041081), received between Oct 24, 2019 and Dec 11, 2024 — classified as 29 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (15 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 Osseointegrate15
- Loss of Osseointegration10
- Osseointegration Problem7
- Patient Device Interaction Problem6
- Insufficient Device Problem Information3
- Loosening of Implant Not Related to Bone-Ingrowth2
- Contamination1
Patient problems
- Failure of Implant21
- Inadequate Osseointegration8
- Pain4
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 7, 2024Contamination; Contamination
IMPLANT WAS DROPPED AT TIME OF SURGERY CONTAMINATION.
Patient problems: Failure of Implant
MAUDE report 20629892 ↗InjurySep 9, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJun 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 9, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryApr 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
InjuryMar 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
InjuryFeb 14, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 13, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 13, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 5, 2023Failure to Osseointegrate; Osseointegration Problem; Patient Device Interaction Problem; Failure to Osseointegrate; Osseointegration Problem; Patient Device Interaction Problem
InjuryJul 5, 2023Loss of Osseointegration; Osseointegration Problem; Patient Device Interaction Problem; Loss of Osseointegration; Osseointegration Problem; Patient Device Interaction Problem
InjuryJul 5, 2023Failure to Osseointegrate; Loss of Osseointegration; Osseointegration Problem; Patient Device Interaction Problem; Failure to Osseointegrate; Loss of Osseointegration; Osseointegration Problem; Patient Device Interaction Problem
PRIMARY STABILITY WAS ACHIEVED BUT IMPLANT DID NOT INTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17260652 ↗InjuryJul 5, 2023Failure to Osseointegrate; Loss of Osseointegration; Osseointegration Problem; Patient Device Interaction Problem; Failure to Osseointegrate; Loss of Osseointegration; Osseointegration Problem; Patient Device Interaction Problem
InjuryJun 26, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 26, 2023Failure to Osseointegrate; Loss of Osseointegration; Osseointegration Problem; Patient Device Interaction Problem; Failure to Osseointegrate; Loss of Osseointegration; Osseointegration Problem; Patient Device Interaction Problem
InjuryMar 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryNov 10, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 21, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 21, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 21, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 3, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
PAIN AND FISTULA WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant; Pain
MAUDE report 10938325 ↗
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.