Infinity External Hex Implant System 403311Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00614950005376), received between Mar 8, 2016 and Apr 24, 2020 — classified as 12 injuries.

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

• InjuryApr 24, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN AND MOBILITY 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 AND OSSEOINTEGRATION WAS NOT ACHIEVED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 9995496 ↗
• InjuryNov 18, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. MOBILITY AND PAIN WERE REPORTED. 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 IS A SMOKER.

  Patient problems: Failure of Implant; Pain

  MAUDE report 9335309 ↗
• InjuryJan 28, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 8281137 ↗
• InjuryJan 25, 2019Failure 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 (NUOSS) WAS PERFORMED. PATIENT HAS DIABETES.

  Patient problems: Failure of Implant

  MAUDE report 8278826 ↗
• InjuryMay 10, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  POOR ORAL HYGIENE, PAIN AND SWELLING 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 NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant; Pain; Swelling

  MAUDE report 7504242 ↗
• InjuryDec 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 7137555 ↗
• InjurySep 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PERI-IMPLANTITIS, INFECTION AND ASINTOMATICA WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE IV. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 6844988 ↗
• InjuryApr 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY WAS REPORTED. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III.

  Patient problems: Failure of Implant

  MAUDE report 6516104 ↗
• InjuryDec 29, 2016Osseointegration Problem; Osseointegration Problem

  INFECTION WAS REPORTED. NO OSSEOINTEGRATION 0-3 MONTHS BEFORE RESTORATION.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 6214372 ↗
• InjuryDec 29, 2016Osseointegration Problem; Osseointegration Problem

  NO OSSEOINTEGRATION WAS REPORTED. NO OSSEOINTEGRATION OF THE IMPLANT 0-6 MONTHS BEFORE RESTORATION.

  Patient problems: Failure of Implant

  MAUDE report 6214357 ↗
• InjuryAug 10, 2016Osseointegration Problem; Osseointegration Problem

  NO OSSEOINTEGRATION OF THE IMPLANT. PAIN AND BONE LOSS WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 5864553 ↗
• InjuryMar 8, 2016Osseointegration Problem; Osseointegration Problem

  PRIMARY STABILITY WAS ACHIEVED BUT OSSEOINTEGRATION WAS NOT. INFECTION WAS ALSO REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS LESS THAN 1 YEAR AFTER THE PLACEMENT OF THE PROSTHESIS. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE III.

  Patient problems: Failure of Implant

  MAUDE report 5487096 ↗