Infinity External Hex Implant System 404710Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00614950005512), received between Dec 15, 2015 and Jan 28, 2019 — classified as 15 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BLEEDING, NUMBNESS, FISTULA, PERI-IMPLANTITIS AND INFECTION WERE 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 AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Fistula; Unspecified Infection

  MAUDE report 8281138 ↗
• InjuryMay 7, 2018Failure 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 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

  MAUDE report 7490103 ↗
• InjuryJan 12, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN 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 AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7185253 ↗
• InjuryDec 21, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BLEEDING, SWELLING, NUMBNESS 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.

  Patient problems: Failure of Implant; Swelling

  MAUDE report 7137426 ↗
• InjuryDec 20, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  SWELLING 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 AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Swelling

  MAUDE report 7135137 ↗
• InjuryNov 13, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  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 NOT ACHIEVED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7024615 ↗
• InjuryMar 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY AND ASYMPTOMATIC 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 ACHIEVED.

  Patient problems: Failure of Implant

  MAUDE report 6432553 ↗
• InjuryMar 3, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INFECTION AND NO OSSEOINTEGRATION WERE REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 6375924 ↗
• InjuryDec 29, 2016Osseointegration Problem; Osseointegration Problem

  NO OSSEOINTEGRATION WAS REPORTED. NO OSSEOINTEGRATION 1-3 MONTHS BEFORE RESTORATION.

  Patient problems: Failure of Implant

  MAUDE report 6214363 ↗
• InjuryNov 7, 2016Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 6083468 ↗
• InjuryOct 24, 2016Osseointegration Problem; Osseointegration Problem

  PAIN WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1-3 MONTHS BEFORE PROSTHETIC RESTORATION. IT WAS ALSO REPORTED NO OSSEOINTEGRATION OF THE IMPLANT. PATIENT IS A SMOKER AND HAS HYPERTENSION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6052087 ↗
• InjuryJul 15, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS MORE THAN A YEAR AFTER FINAL RESTORATION. NO OSSEOINTEGRATION OF THE IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 5798115 ↗
• InjuryJul 15, 2016Osseointegration Problem; Osseointegration Problem

  BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS LOW. NO OSSEOINTEGRATION OF THE IMPLANT. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant

  MAUDE report 5798105 ↗
• InjuryDec 22, 2015Failure to Osseointegrate; Osseointegration Problem

  NO OSSEOINTEGRATION WAS REPORTED AT TIME OF FAILURE.

  Patient problems: Failure of Implant

  MAUDE report 5319825 ↗
• InjuryDec 15, 2015Osseointegration Problem

  MOBILITY, BONE LOSS AND PAIN WAS REPORTED AT THE TIME OF IMPLANT FAILURE

  Patient problems: Failure of Implant

  MAUDE report 5297439 ↗