Infinity External Hex Implant System 404713Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00614950005536), received between Dec 23, 2015 and Jan 25, 2019 — classified as 9 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (8 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.

• InjuryJan 25, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  ASYMPTOMATIC AND INFECTION 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. "AUMENTATION" PROCEDURE WAS NOT PERFORMED.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 8278817 ↗
• InjuryJan 25, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INFECTION 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.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 8278812 ↗
• InjurySep 22, 2017Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  ASYMPTOMATIC, ASYMPTOMATIC AND BONE LOSS 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 WAS PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 6888438 ↗
• InjuryDec 14, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. NO OSSEOINTEGRATION OF THE IMPLANT 1-3 MONTHS AFTER FINAL RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT SURGERY TYPE II. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant

  MAUDE report 6173271 ↗
• InjuryAug 19, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. PRIMARY STABILITY OSSEOINTEGRATION WAS NOT ACHIEVED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. IT WAS REPORTED INADEQUATE BONE QUALITY AND BONE WAS TOO THIN ON FACIAL AND COULD NOT SEE SOME THREADS.

  Patient problems: Failure of Implant

  MAUDE report 5890608 ↗
• InjuryJun 1, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 5692924 ↗
• InjuryMar 9, 2016Osseointegration Problem; Osseointegration Problem

  TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE RESTORATION. PRIMARY STABILITY WAS ACHIEVED BUT OSSEOINTEGRATION WAS NOT. ACHIEVED. ASYMPTOMATIC AND MOBILITY WAS REPORTED. PAIN ALSO WAS REPORTED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE III.

  Patient problems: Failure of Implant

  MAUDE report 5488975 ↗
• InjuryFeb 4, 2016Osseointegration Problem; Osseointegration Problem

  N/A

  Patient problems: Failure of Implant

  MAUDE report 5409971 ↗
• InjuryDec 23, 2015Failure to Osseointegrate

  MOBILITY AND PAIN WAS REPORTED AT THE TIME OF IMPLANT FAILURE. NO OSSEOINTEGRATION BEFORE 3-6 MONTHS OF FINAL DENTAL RESTORATION.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 5324977 ↗