infinity OCTAGON 504808BLRecalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Bone Level Implant Regular Connect Ø4.8x8 · Class 2 · Implant
All models of infinity OCTAGON (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI E0HM504808BL1), received between Mar 13, 2019 and Sep 29, 2023 — classified as 11 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (5 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.
Most reported problems
Device problems
- Failure to Osseointegrate5
- Patient Device Interaction Problem3
- Loss of Osseointegration2
- Osseointegration Problem2
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant6
- Inadequate Osseointegration5
- Pain2
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjurySep 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjurySep 11, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryJul 5, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryApr 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMar 7, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 10, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
INADEQUATE BONE QUALITY/BONE QUANTITY WAS 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 problems: Failure of Implant; Pain
MAUDE report 11310910 ↗InjuryOct 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
POOR ORAL HYGIENE, PAIN AND MOBILITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant; Pain
MAUDE report 9232356 ↗InjuryMar 13, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
INADEQUATE BONE QUALITY/BONE QUANTITY AND ASYMPTOMATIC WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE IV. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT HAS DIABETES MELLITUS.
Patient problems: Failure of Implant
MAUDE report 8417198 ↗
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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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