Infinity External Hex Implant System 403713Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00614950005437), received between Feb 1, 2016 and Jun 27, 2019 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INADEQUATE BONE QUALITY/BONE QUANTITY, PAIN, BLEEDING AND FISTULA 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. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT HAS LYMPHATIC DISORDER.

  Patient problems: Failure of Implant; Fistula; Pain

  MAUDE report 8738599 ↗
• InjuryMay 10, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  FISTULA, PERI-IMPLANTITIS AND BLEEDING 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 NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant; Fistula

  MAUDE report 7504244 ↗
• InjuryMay 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  FISTULA, BIOMECH. OVERLOAD AND MOBILITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1-5 YEARS AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED.

  Patient problems: Failure of Implant; Fistula

  MAUDE report 7504240 ↗
• InjuryFeb 23, 2017Product Quality Problem

  MOBILITY, INADEQUATE BONE QUALITY AND PAIN WERE REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE IV. PATIENT WAS UNDERGOING CHEMOTHERAPY AT THE TIME OF IMPLANTATION.

  Patient problems: Failure of Implant

  MAUDE report 6353333 ↗
• InjuryJan 31, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE DISCOVERY. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III.

  Patient problems: Failure of Implant

  MAUDE report 6290255 ↗
• InjuryAug 10, 2016Osseointegration Problem; Osseointegration Problem

  GRANULOMA AND PAIN WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. PATIENT HAS HEART PROBLEMS.

  Patient problems: Failure of Implant; Pain

  MAUDE report 5864574 ↗
• InjuryAug 10, 2016Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 5864566 ↗
• InjuryJun 17, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY AND PAIN WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE III. PATIENT HAS HYPERTENSION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 5732541 ↗
• InjuryMay 9, 2016Osseointegration Problem; Osseointegration Problem

  IMPLANT FAILURE DUE TO MOBILITY AND INFECTION. NO OSSEOINTEGRATION 3-6 MONTHS BEFORE DISCOVERY. PATIENT HAS CANCER. BONE LOSS WAS ALSO REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 5641290 ↗
• InjuryFeb 1, 2016Osseointegration Problem; Osseointegration Problem

  INFECTION, MOBILITY AND PAIN WAS REPORTED. 1-3 MONTHS BEFORE DISCOVERY. IT WAS ALSO REPORTED THE PATIENT HAS DIABETES.

  Patient problems: Failure of Implant

  MAUDE report 5403281 ↗
• InjuryFeb 1, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY AND PRIMARY STABILITY WAS REPORTED. RELATIONSHIP OF TIME BETWEEN THE PLACEMENT AND THE LOSS OF THE IMPLANT WAS BEFORE RESTORATION.

  Patient problems: Failure of Implant

  MAUDE report 5402568 ↗