infinity OCTAGON 504108BLRecalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Bone Level Implant Regular Connect Ø4.1x8 · Class 2 · Implant
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI E0HM504108BL1), received between Oct 5, 2022 and Mar 17, 2025 — classified as 23 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate13
- Patient Device Interaction Problem6
- Loss of Osseointegration2
- Adverse Event Without Identified Device or Use Problem1
- Inadequacy of Device Shape and/or Size1
Patient problems
- Inadequate Osseointegration14
- Failure of Implant9
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 11, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 11, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MISSING PRIMARY STABILITY (INADEQUATE BONE QUALITY/BONE QUANTITY).
Patient problems: Inadequate Osseointegration
MAUDE report 20900269 ↗InjuryDec 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 7, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IMPLANT FAILED WHEN PLACED SAME DAY SPINNER.
Patient problems: Failure of Implant
MAUDE report 20629897 ↗InjurySep 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 11, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMar 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
InjurySep 26, 2023Failure to Osseointegrate; Failure to Osseointegrate
1 MONTH POST OP BONE LOSS & NO INTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17821897 ↗InjurySep 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryJul 6, 2023Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION. IMPLANT CAME OUT 9 DAYS LATER.
Patient problems: Failure of Implant
MAUDE report 17265876 ↗InjuryApr 13, 2023Failure to Osseointegrate; Failure to Osseointegrate
TRANSFER MOUNT COULD NOT BE REMOVED FROM THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 16731625 ↗InjuryMar 28, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMar 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT WAS A SMOKER, IMPLANT DID NOT OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16610684 ↗InjuryMar 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryDec 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 5, 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.