Infinity Internal Hex System 214710Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00614950007189), received between May 7, 2020 and Jan 25, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 2024Failure to Osseointegrate; Failure to Osseointegrate

  MOBILITY.

  Patient problems: Failure of Implant

  MAUDE report 18581304 ↗
• MalfunctionMay 22, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  UPON PLACEMENT, WHEN ATTEMPTING TO REMOVE THE CARRIER UNSUCCESSFUL. THE IMPLANT HAD TO BE BACKED OUT OF THE SURGICAL SITE AND ANOTHER IMPLANT PLACED.

  Patient problems: Failure of Implant

  MAUDE report 16975748 ↗
• InjuryJun 9, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  MOBILITY WAS REPORTED. BONE QUALITY WAS IDENTIFIED AS TYPE II AND TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 11965894 ↗
• InjuryJun 2, 2021Failure to Osseointegrate

  BONE QUALITY WAS TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS NOT ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS PERFORMED AT THE TIME OF SURGERY (BONE GRAFT AND 1 COLLAGEN PLUG).

  Patient problems: Failure of Implant

  MAUDE report 11923232 ↗
• InjuryJan 5, 2021Failure 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 AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE (ALLOGRAFT) WAS PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 11120267 ↗
• InjuryMay 7, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE I. 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 10032724 ↗