infinity OCTAGON 504810Recalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Tissue Level Implant Regular Platform Ø4,8x10 · Class 2 · Implant
Quick summary
This Infinity Octagon dental implant is a root-form implant placed in the jaw to hold dental replacements. Reports mostly describe implants that did not bond with the bone and had to be removed, sometimes within days, plus a broken implant. The 24 reports mention no deaths and 23 injuries. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI E0HM5048101), received between Jun 21, 2022 and Dec 11, 2024 — classified as 23 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (13 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 Osseointegrate13
- Osseointegration Problem5
- Patient Device Interaction Problem5
- Loss of Osseointegration3
- Fracture1
Patient problems
- Inadequate Osseointegration13
- Failure of Implant11
- Pain1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 2, 2024Fracture; Fracture
InjurySep 9, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJun 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
2 DAYS AFTER SURGERY THE IMPLANT WAS REMOVED OR LOST.
Patient problems: Failure of Implant
MAUDE report 19597721 ↗InjuryApr 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 10, 2024Osseointegration Problem; Osseointegration Problem
InjuryJan 10, 2024Osseointegration Problem; Osseointegration Problem
InjuryNov 8, 2023Osseointegration Problem; Osseointegration Problem
InjurySep 27, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryAug 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryAug 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 13, 2023Loss of Osseointegration; Loss of Osseointegration
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
InjuryApr 3, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT IN OCCLUSION FOR APPROX 18 MONTHS BEFORE IT BECAME MOBILE. IT WAS REMOVED AND BONE WAS RE-GRAFTED.
Patient problems: Failure of Implant
MAUDE report 16667680 ↗InjuryApr 3, 2023Osseointegration Problem; Osseointegration Problem
INTERMITTENT SENSITIVITY AROUND CROWN. THE WHOLE IMPLANT CAME OUT.
Patient problems: Failure of Implant; Pain
MAUDE report 16665867 ↗MalfunctionSep 1, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
MISSING PRIMARY STABILITY. "BUCCAL DEFECT SURGEON TRIED 3 IMPLANTS; NONE OF THEM ENGAGED, PROBABLY NOT ENOUGH THREAD, DECIDED TO GRAFT FIRST AND WAIT 3-4 MONTH" SEE ALSO REPORTS 8010516-2022-00113 AND 8010516-2022-00114.
Patient problems: Inadequate Osseointegration
MAUDE report 15333218 ↗InjuryJun 21, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 21, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 21, 2022Failure 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.