infinity OCTAGON 504110BLRecalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Bone Level Implant Regular Connect Ø4.1x10 · Class 2 · Implant
Quick summary
This Hager & Meisinger Infinity Octagon bone-level dental implant is a root-form screw placed into the jaw. The 32 reports mostly describe the implant failing to fuse with the surrounding bone, so it loses stability or does not achieve primary stability, sometimes with pain, fistula or infection noted. There are 31 injuries and no deaths, and 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
- 32
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI E0HM504110BL1), received between Mar 13, 2019 and Sep 9, 2024 — classified as 31 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (19 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 Osseointegrate19
- Patient Device Interaction Problem10
- Osseointegration Problem7
- Loss of Osseointegration3
- Device Fell1
- Unstable1
Patient problems
- Failure of Implant20
- Inadequate Osseointegration10
- Fistula2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2024Loss of Osseointegration; Loss of Osseointegration
InjurySep 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryApr 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryApr 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryApr 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 11, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 30, 2023Loss of Osseointegration; Loss of Osseointegration
PATIENT RETURNED AFTER 6 MONTHS WITH IMPLANT MOBILITY BUT NO PAIN. IMPLANT WAS REMOVED.
Patient problems: Failure of Implant
MAUDE report 18241479 ↗InjuryNov 13, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryJul 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE IMPLANT WAS ROTATING SO PRIMARY STABILITY WAS NOT ACHIEVED.
Patient problems: Failure of Implant
MAUDE report 17353193 ↗InjuryMay 25, 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 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMar 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT WAS A SMOKER, FAILED TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16600544 ↗InjuryMar 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMar 7, 2023Failure to Osseointegrate; Failure to Osseointegrate
MISSING PRIMARY STABILITY, FAILED OSSEOINTEGRATION AFTER 2 MONTH.
Patient problems: Inadequate Osseointegration
MAUDE report 16493899 ↗InjuryNov 22, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 5, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryJul 1, 2022Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionJul 1, 2022Device Fell
IMPLANT FELL ONTO INSTRUMENT TRAY WHILE REMOVING FROM DELIVERY PACKAGING
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14884430 ↗
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.