infinity OCTAGON 504808WPRecalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Tissue Level Implant Wide Platform Ø4,8x8 · Class 2 · Implant
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI E0HM504808WP1), received between Jun 21, 2022 and Jan 9, 2025 — classified as 20 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (7 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 Osseointegrate7
- Patient Device Interaction Problem5
- Osseointegration Problem3
- Difficult to Remove2
- Loss of Osseointegration2
- Device Fell1
Patient problems
- Inadequate Osseointegration9
- Failure of Implant8
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2025Loss of Osseointegration; Loss of Osseointegration
2 MONTHS AFTER RESTORATION THE PATIENT STARTED FEELING PAIN.
Patient problems: Failure of Implant
MAUDE report 21119550 ↗InjuryJun 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 4, 2024Loss of Osseointegration; Loss of Osseointegration
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
InjuryJan 16, 2024Osseointegration Problem; Osseointegration Problem
AFTER PLACEMENT OF CROWN, IMPLANT WAS LOOSE. WEAK OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18518279 ↗InjuryJan 10, 2024Osseointegration Problem; Osseointegration Problem
InjuryJan 10, 2024Osseointegration Problem; Osseointegration Problem
InjurySep 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 29, 2023Difficult to Remove; Difficult to Remove
PROBLEM REMOVING IMPLANT FROM HOLDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17841100 ↗InjurySep 29, 2023Difficult to Remove; Difficult to Remove
PROBLEM REMOVING IMPLANT FROM VIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17841097 ↗InjurySep 29, 2023Device Fell; Device Fell
IMPLANT FELL OF MOUNT ON FLOOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17841095 ↗InjurySep 29, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryAug 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryOct 28, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 28, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 28, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 21, 2022Failure to Osseointegrate; Failure to Osseointegrate
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.