infinity OCTAGON 503310BLRecalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Bone Level Implant Narrow Connect Ø3.3x10 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI E0HM503310BL1), received between Nov 18, 2019 and Apr 30, 2025 — classified as 21 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (14 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 Osseointegrate14
- Osseointegration Problem9
- Patient Device Interaction Problem8
- Loss of Osseointegration4
Patient problems
- Failure of Implant16
- Inadequate Osseointegration5
- Swelling1
- Unspecified Infection1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
InjurySep 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryAug 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryJul 27, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT WAS SPINNING IN THE SOCKET; SOFT BONE.
Patient problems: Failure of Implant
MAUDE report 17409127 ↗InjuryJul 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 16, 2023Loss of Osseointegration; Loss of Osseointegration
CHRONIC PERI IMPLANTITIS #7.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 17148137 ↗InjuryJun 7, 2023Failure to Osseointegrate; Osseointegration Problem; Patient Device Interaction Problem; Failure to Osseointegrate; Osseointegration Problem; Patient Device Interaction Problem
InjuryJun 6, 2023Failure to Osseointegrate; Failure to Osseointegrate
BONE LOSS NOTICED AROUND CIRCUMFERENCE OF IMPLANT.
Patient problems: Failure of Implant
MAUDE report 17070856 ↗InjuryMay 26, 2023Failure to Osseointegrate; Loss of Osseointegration; Osseointegration Problem; Patient Device Interaction Problem; Failure to Osseointegrate; Loss of Osseointegration; Osseointegration Problem; Patient Device Interaction Problem
InjuryMay 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMay 26, 2023Failure to Osseointegrate; Loss of Osseointegration; Osseointegration Problem; Patient Device Interaction Problem; Failure to Osseointegrate; Loss of Osseointegration; Osseointegration Problem; Patient Device Interaction Problem
InjuryMay 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryAug 10, 2022Failure to Osseointegrate
InjuryApr 29, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
INADEQUATE BONE QUALITY/BONE QUANTITY, 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 11746088 ↗InjuryFeb 15, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
MOBILITY AND INADEQUATE BONE QUALITY/BONE QUANTITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE IV. 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 HAS DIABETES.
Patient problems: Failure of Implant
MAUDE report 11330038 ↗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 11310706 ↗InjuryDec 18, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
MOBILITY 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED.
Patient problems: Failure of Implant
MAUDE report 11037745 ↗InjuryNov 16, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
MOBILITY 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER.
Patient problems: Failure of Implant
MAUDE report 10842611 ↗InjuryNov 18, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. BLEEDING AND SWELLING WERE REPORTED. TIME OF LOSS IN RELATION TOT HE 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; Swelling
MAUDE report 9335322 ↗
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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 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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