Infinity External Hex Implant System 404013Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00614950005482), received between Dec 15, 2015 and Nov 3, 2020 — classified as 17 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2020Osseointegration Problem; Osseointegration Problem

  PAIN, BLEEDING 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 10777416 ↗
• InjuryMay 6, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN, MOBILITY, POOR ORAL HYGIENE, PERI-IMPLANTITIS AND INADEQUATE BONE QUALITY/BONE QUANTITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1 TO 5 YEARS AFTER 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 8584252 ↗
• InjuryMay 6, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN, SWELLING AND MOBILITY 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 IS A SMOKER.

  Patient problems: Failure of Implant; Pain; Swelling

  MAUDE report 8584249 ↗
• 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. PATIENT HAS DIABETES.

  Patient problems: Failure of Implant

  MAUDE report 8278822 ↗
• InjuryOct 19, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

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

  Patient problems: Failure of Implant; Pain; Swelling

  MAUDE report 7983343 ↗
• InjuryJan 9, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  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 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; Pain

  MAUDE report 7174644 ↗
• InjuryJan 9, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN, BLEEDING AND PERI-IMPLANTITIS 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 problems: Failure of Implant; Pain

  MAUDE report 7174643 ↗
• InjuryJan 9, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 7174640 ↗
• InjuryJun 1, 2016Osseointegration Problem; Osseointegration Problem

  PAIN AND MOBILITY WAS REPORTED. NO OSSEOINTEGRATION AFTER MORE THAN A YEAR.

  Patient problems: Failure of Implant; Pain

  MAUDE report 5692936 ↗
• InjuryJun 1, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY AND PAIN WAS REPORTED. NO OSSEOINTEGRATION OF THE IMPLANT IN MORE THAN A YEAR.

  Patient problems: Failure of Implant; Pain

  MAUDE report 5692930 ↗
• InjuryMay 9, 2016Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant

  MAUDE report 5641296 ↗
• InjuryMar 28, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. BONE DENSITY WAS 0-1 MONTHS. IT WAS REPORTED THE PATIENT IS A SMOKER AND HAS HYPERTENSION.

  Patient problems: Failure of Implant

  MAUDE report 5528843 ↗
• InjuryMar 28, 2016Osseointegration Problem; Osseointegration Problem

  PAIN AND MOBILITY WAS REPORTED. NO OSSEOINTEGRATION OF THE IMPLANT BEFORE DISCOVERY 3-6 MONTHS.

  Patient problems: Failure of Implant

  MAUDE report 5528724 ↗
• InjuryMar 28, 2016Osseointegration Problem; Osseointegration Problem

  PAIN AND MOBILITY WAS REPORTED. NO OSSEOINTEGRATION OF THE IMPLANT BEFORE DISCOVERY 3-6 MONTHS.

  Patient problems: Failure of Implant

  MAUDE report 5528721 ↗
• InjuryFeb 1, 2016Osseointegration Problem; Osseointegration Problem

  INFECTION, MOBILITY AND PAIN WAS REPORTED. NO OSSEOINTEGRATION. ONE (1) - THREE (3) MONTHS BEFORE DISCOVERY. IT WAS ALSO REPORTED THE PATIENT IS A SMOKER.

  Patient problems: Failure of Implant

  MAUDE report 5402545 ↗
• InjuryDec 15, 2015Osseointegration Problem

  MOBILITY WAS REPORTED AT THE TIME OF IMPLANT FAILURE. NO OSSEOINTEGRATION AFTER 1-3 MONTHS OF FINAL DENTAL RESTORATION.

  Patient problems: Failure of Implant

  MAUDE report 5298429 ↗
• InjuryDec 15, 2015Osseointegration Problem

  INFECTION WAS REPORTED AT THE TIME OF IMPLANT FAILURE. PERI-IMPLANTITIS WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 5297352 ↗