infinity OCTAGON 504112BLRecalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Bone Level Implant Regular Connect Ø4.1x12 · Class 2 · Implant
All models of infinity OCTAGON (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI E0HM504112BL1), received between Oct 24, 2019 and Dec 2, 2024 — classified as 17 injuries.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate13
- Osseointegration Problem4
- Loss of Osseointegration2
- Patient Device Interaction Problem2
Patient problems
- Failure of Implant10
- Inadequate Osseointegration7
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryDec 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMar 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
InjurySep 26, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 27, 2023Loss of Osseointegration; Loss of Osseointegration
AT RECALL IT WAS FOUND THAT #9 HAD SLIGHT MOBILITY. REMOVED CROWN AND IMPLANT WAS NOT STABLE.
Patient problems: Failure of Implant
MAUDE report 17409123 ↗InjuryJul 5, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT WAS NEVER OSSEOINTEGRATED AND BECAME LOOSE.
Patient problems: Failure of Implant
MAUDE report 17258520 ↗InjuryJun 15, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT WAS PLACED (B)(6) 2022, PLACED LOCATER ON (B)(6) 2022 DURING FINAL TORQUE IMPLANT SLIGHTLY TURNED SO WE DID NOT ENGAGE DENTURE TO LOCATER THEN THE IMPLANT FAILED.
Patient problems: Failure of Implant
MAUDE report 17137543 ↗InjuryMay 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
INFECTION #5 IMPLANT AT 2 WEEKS JUST AFTER STOPPING ABRX.
Patient problems: Failure of Implant
MAUDE report 16951843 ↗InjuryApr 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT WAS A SMOKER. IMPLANT DID NOT OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16617961 ↗InjuryNov 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 18, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 10, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
MOBILITY AND ASYMPTOMATIC 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 11310685 ↗InjuryFeb 9, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
ASYMPTOMATIC, MOBILITY AND PREVIOUS BONE AUGMENTATION ((B)(6) 2020) 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
MAUDE report 11302540 ↗InjuryDec 18, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
PERI-IMPLANTITIS AND ASYMPTOMATIC 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER AND HAS DIABETES.
Patient problems: Failure of Implant
MAUDE report 11037754 ↗InjuryOct 24, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
INADEQUATE BONE QUALIY/BONE QUANTITY AND POOR ORAL HYGIENE 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMETATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER.
Patient problems: Failure of Implant
MAUDE report 9232361 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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