infinity OCTAGON 504810BLRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI E0HM504810BL1), received between Mar 13, 2019 and Aug 14, 2023 — classified as 24 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (20 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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS NOT POSSIBLE TO REMOVE TRANSFER PART FROM IMPLANT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17538824 ↗
• InjuryAug 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MISSING OSSEOINTEGRATION, SAME PATIENT AS CASE (B)(4).

  Patient problems: Inadequate Osseointegration

  MAUDE report 17498231 ↗
• InjuryAug 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MISSING OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17498093 ↗
• InjuryAug 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MISSING OSSEOINTEGRATION, SAME PATIENT AS CASE (B)(4).

  Patient problems: Inadequate Osseointegration

  MAUDE report 17498091 ↗
• InjuryMay 23, 2023Failure to Osseointegrate; Osseointegration Problem; Patient Device Interaction Problem; Failure to Osseointegrate; Osseointegration Problem; Patient Device Interaction Problem

  SAME DAY SPINNER.

  Patient problems: Failure of Implant

  MAUDE report 16988135 ↗
• InjuryMay 23, 2023Failure to Osseointegrate; Failure to Osseointegrate

  SAME DAY SPINNER.

  Patient problems: Failure of Implant

  MAUDE report 16988063 ↗
• InjuryMay 22, 2023Failure to Osseointegrate; Failure to Osseointegrate

  SAME DAY SPINNER.

  Patient problems: Failure of Implant

  MAUDE report 16976446 ↗
• InjuryMay 19, 2023Failure to Osseointegrate; Failure to Osseointegrate

  1.5 MONTHS POST PLACEMENT THE IMPLANT WAS ACUTELY INFECTED WITH 90% BONE LOSS.

  Patient problems: Failure of Implant

  MAUDE report 16963497 ↗
• InjuryMay 18, 2023Failure to Osseointegrate; Failure to Osseointegrate

  AT 1.5 MONTHS POST PLACEMENT THE IMPLANT WAS ACUTELY INFECTED WITH 90% BONE LOSS.

  Patient problems: Failure of Implant

  MAUDE report 16951844 ↗
• InjuryMay 18, 2023Failure to Osseointegrate; Failure to Osseointegrate

  AT 1.5 MONTHS POST PLACEMENT IMPLANT WAS ACUTELY INFECTED WITH 90% BONE LOSS.

  Patient problems: Failure of Implant

  MAUDE report 16951842 ↗
• InjuryApr 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MISSING PRIMARY STABILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16774746 ↗
• InjuryApr 19, 2023Failure to Osseointegrate; Failure to Osseointegrate

  MISSING OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16767570 ↗
• InjuryApr 13, 2023Failure to Osseointegrate; Failure to Osseointegrate

  PATIENT'S GENERAL DENTIST FOUND BONE LOSS AROUND IMPLANT AFTER 10 MONTHS. IMPLANT REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 16732371 ↗
• InjuryNov 22, 2022Failure to Osseointegrate; Failure to Osseointegrate

  MISSING OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15841931 ↗
• InjuryFeb 10, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  ASYMPTOMATIC 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

  MAUDE report 11310980 ↗
• InjuryFeb 10, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  ASYMPTOMATIC 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 problems: Failure of Implant

  MAUDE report 11310635 ↗
• InjuryFeb 9, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  ASYMPTOMATIC, MOBILITY AND PREVIOUS BONE AUGMENTATION ((B)(6) 2020) WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE (SINUS LIFT) WAS PERFORMED AT THE TIME OF SURGERY. PATIENT HAS HIGH BLOOD PRESSURE.

  Patient problems: Failure of Implant

  MAUDE report 11302558 ↗
• InjuryOct 24, 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 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 9232372 ↗
• InjuryMay 22, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY . PATIENT IS ALLERGIC TO PENICILLIN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8634051 ↗
• InjuryMay 22, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  SWELLING, FISTULA, INFECTION 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 problems: Failure of Implant; Swelling; Unspecified Infection

  MAUDE report 8634042 ↗
• 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 BEFORE 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 8417232 ↗
• 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 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 HAS DIABETES MELLITUS.

  Patient problems: Failure of Implant

  MAUDE report 8417204 ↗
• 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 BEFORE 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 8417203 ↗
• InjuryMar 13, 2019Failure 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 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 PSYCHOLOGICAL DISORDER.

  Patient problems: Failure of Implant

  MAUDE report 8417190 ↗