infinity OCTAGON Bone Level Taper Dental Implant BLT504112Recalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · infinity OCTAGON Bone Level Taper Dental Implant 4.1x12 mm Regular Platform · Class 2 · Implant
All models of infinity OCTAGON Bone Level Taper Dental Implant (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI E0HMBLT5041121), received between Feb 8, 2021 and Jul 13, 2023 — classified as 8 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Failure to Osseointegrate4
- Patient Device Interaction Problem2
- Activation, Positioning or Separation Problem1
- Loss of Osseointegration1
- Osseointegration Problem1
Patient problems
- Failure of Implant5
- Inadequate Osseointegration3
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJul 13, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PROBLEM REMOVING IMPLANT FROM VIAL. HAD TO PLACE A NEW IMPLANT.
Patient problems: Failure of Implant
MAUDE report 17317105 ↗InjuryJul 5, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryJun 1, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
OUT OF BOX FAILURE - NOT UNLOCKING. UNABLE TO USE PRODUCT.
Patient problems: Failure of Implant
MAUDE report 17043689 ↗InjuryMay 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryApr 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 8, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
DOCTOR NEEDED A DIFFERENT SIZE AND MOBILITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER.
Patient problems: Failure of Implant
MAUDE report 11297061 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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