Infinity Internal Hex System 205116Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00614950004836), received between Mar 1, 2016 and May 30, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  SAME DAY SPINNER.

  Patient problems: Failure of Implant

  MAUDE report 17020146 ↗
• InjuryOct 19, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE IV. 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 12657208 ↗
• InjuryOct 18, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

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

  Patient problems: Failure of Implant

  MAUDE report 12647871 ↗
• InjuryJun 9, 2021Failure to Osseointegrate; Patient Device Interaction Problem; Failure to Osseointegrate; Patient Device Interaction Problem

  TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED.

  Patient problems: Failure of Implant

  MAUDE report 11967237 ↗
• InjuryJan 31, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  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.

  Patient problems: Failure of Implant

  MAUDE report 9655302 ↗
• InjuryFeb 18, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY WAS 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 AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 8347425 ↗
• InjuryAug 25, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. NO OSSEOINTEGRATION OF THE IMPLANT AFTER FINAL RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE IV.

  Patient problems: Failure of Implant

  MAUDE report 5904289 ↗
• InjuryAug 2, 2016Osseointegration Problem; Osseointegration Problem

  NO OSSEOINTEGRATION OF THE IMPLANT 0-1 MONTHS BEFORE DISCOVERY. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE I. PATIENT IS A SMOKER AND HAS DIABETES.

  Patient problems: Failure of Implant

  MAUDE report 5839740 ↗
• InjuryMar 1, 2016Osseointegration Problem; Osseointegration Problem

  TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY DID NOT ENGAGE SECURELY.

  Patient problems: Failure of Implant

  MAUDE report 5471072 ↗