Infinity Internal Hex System 214711Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00614950007196), received between Sep 1, 2016 and Jul 25, 2023 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2023Failure to Osseointegrate; Failure to Osseointegrate

  PROBLEM OSSEOINTEGRATION.

  Patient problems: Failure of Implant

  MAUDE report 17393368 ↗
• InjuryJun 5, 2023Failure to Osseointegrate; Failure to Osseointegrate

  SAME DAY SPINNER.

  Patient problems: Failure of Implant

  MAUDE report 17062705 ↗
• InjuryMar 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  SAME DAY SPINNER.

  Patient problems: Failure of Implant

  MAUDE report 16598821 ↗
• InjuryOct 21, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PERI-IMPLANTITIS AND MOBILITY 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 ACHIEVED. AUGMENTATION PROCEDURE (ALLOGRAFT) WAS PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 12677185 ↗
• InjuryApr 12, 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 11648042 ↗
• InjuryMar 25, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 8447521 ↗
• InjurySep 1, 2016Osseointegration Problem; Osseointegration Problem

  INFECTION WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE III. IMPLANT DID NOT ACHIEVE INTEGRATION.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 5921059 ↗