infinity OCTAGON 504810WPRecalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Tissue Level Implant Wide Platform Ø4,8x10 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This is a wide-platform dental implant made by Hager & Meisinger, used as a root-form screw to anchor a replacement tooth in the jawbone. The 47 reports describe the implant failing to fuse with the surrounding bone, or losing that bond after it had formed, along with difficulty seating it properly. No deaths were reported, and all 47 reports involved an injury. There are no recalls that 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
- 47
- Deaths reported
- 0
- Injuries reported
- 47
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI E0HM504810WP1), received between May 17, 2022 and Mar 24, 2025 — classified as 47 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (29 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 Osseointegrate29
- Loss of Osseointegration6
- Osseointegration Problem6
- Patient Device Interaction Problem5
- Activation, Positioning or Separation Problem1
Patient problems
- Inadequate Osseointegration25
- Failure of Implant22
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
MISSING OSSEOINTEGRATION DUE TO MISSING PRIMARY STABILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19572578 ↗InjuryJun 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 4, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryApr 3, 2024Loss of Osseointegration; Loss of Osseointegration
PATIENT HAD PAIN & SWELLING AFTER OPERATION.
Patient problems: Failure of Implant
MAUDE report 19038196 ↗InjuryApr 3, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
THE IMPLANT BARRIER DIDN'T RELEASE WHEN IMPLANT WAS PLACED.
Patient problems: Failure of Implant
MAUDE report 19038194 ↗InjuryMar 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMar 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMar 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMar 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryFeb 13, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF IMPLANT. LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18698092 ↗InjuryJan 16, 2024Osseointegration Problem; Osseointegration Problem
InjuryJan 16, 2024Osseointegration Problem; Osseointegration Problem
InjuryJan 16, 2024Osseointegration Problem; Osseointegration Problem
InjuryNov 3, 2023Osseointegration Problem; Osseointegration Problem
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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