infinity OCTAGON 504812BLRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI E0HM504812BL1), received between Mar 13, 2019 and Mar 15, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (9 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

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MISSING OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18911798 ↗
• InjuryNov 9, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT IS LOOSE AFTER ONE MONTH AND NO OSSEOINTEGRATION.

  Patient problems: Failure of Implant

  MAUDE report 18103224 ↗
• InjurySep 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MISSING OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17786963 ↗
• InjuryJul 6, 2023Loss of Osseointegration; Loss of Osseointegration

  IMPLANT IS LOOSE & TOOK IT OUT. OSSEOINTEGRATION DIDN'T OCCUR.

  Patient problems: Failure of Implant

  MAUDE report 17265877 ↗
• InjuryJul 1, 2022Failure to Osseointegrate; Failure to Osseointegrate

  MISSING OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14884434 ↗
• InjuryMay 19, 2022Failure to Osseointegrate; Failure to Osseointegrate

  MISSING OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14433720 ↗
• InjuryFeb 10, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  DOCTOR NEEDED A BIGGER IMPLANT 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 11310966 ↗
• InjuryOct 24, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  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 OSSOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 9232363 ↗
• InjuryMay 30, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  ASYMPTOMATIC AND INADEQUATE BONE QUALITY/BONE QUANTITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS 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 8653754 ↗
• 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. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS ALLERGIC TO PENICILLIN AND SHELLFISH.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8634047 ↗
• 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 WAS 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 8634044 ↗
• 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 PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 8417184 ↗