Infinity External Hex Implant System 403708Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00614950005406), received between Mar 1, 2016 and Mar 29, 2021 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 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. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 11581161 ↗
• InjuryAug 1, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INADEQUATE BONE QUALITY/BONE QUANTITY 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 WAS PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 8849805 ↗
• InjuryApr 26, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BLEEDING, MOBILITY, INFECTION, NUMBNESS, FISTULA, ASINTOMATICA AND INADEQUATE BONE QUALITY/BONE QUANTITY WERE 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Fistula; Numbness; Unspecified Infection

  MAUDE report 7464451 ↗
• InjuryApr 26, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN, BLEEDING, SWELLING, INFECTION, NUMBNESS AND INADEQUATE BONE QUALITY/BONE QUANTITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE IV. 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; Pain; Swelling; Unspecified Infection

  MAUDE report 7464433 ↗
• InjuryJan 12, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY, FISTULA AND INFECTION WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT HAS DIABETES.

  Patient problems: Failure of Implant; Fistula; Unspecified Infection

  MAUDE report 7185257 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INFECTION AND SWELLING WAS REPORTED. 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. OSSEONTEGRATION WAS NOT ACHIEVED. AUGMENTATION WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 7019584 ↗
• 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 UP TO 1 YR AFTER RESTORATION.

  Patient problems: Failure of Implant

  MAUDE report 6516095 ↗
• InjuryFeb 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  BLEEDING, SWELLING, NUMBNESS, FISTULA AND ASYMPTOMATIC WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1 YR AFTER FINAL PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II.

  Patient problems: Failure of Implant; Pain; Swelling

  MAUDE report 6353411 ↗
• InjuryFeb 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  BLEEDING, SWELLING, NUMBNESS, FISTULA AND ASYMPTOMATIC WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1 YR AFTER FINAL PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PATIENT HAS ALLERGIES, BLOOD CLOTTING DISORDER AND DIABETES MELLITUS.

  Patient problems: Failure of Implant; Numbness; Swelling

  MAUDE report 6353384 ↗
• InjuryJan 31, 2017Osseointegration Problem; Osseointegration Problem

  MOBILITY AND INADEQUATE BONE QUALITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS LESS THAN 1 YEAR AFTER PROSTHESIS. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant

  MAUDE report 6290272 ↗
• 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 5487103 ↗
• InjuryMar 1, 2016Insufficient Device Problem Information

  MOBILITY WAS REPORTED. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. PERIIMPLANTITIS WAS NOTICED DURING THE IMPLANT SURGERY.

  Patient problems: Inflammation

  MAUDE report 5471088 ↗