Infinity External Hex Implant System 403711Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00614950005420), received between Dec 1, 2015 and Jun 4, 2024 — classified as 44 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (35 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2024Loss of Osseointegration; Loss of Osseointegration

  PERI IMPLANTITIS.

  Patient problems: Failure of Implant

  MAUDE report 19464140 ↗
• InjuryMay 24, 2023Osseointegration Problem; Osseointegration Problem

  TIME OF LOSS IN RELATION TO THE IMPLEMENTATION WAS 1 TO 5 YEARS AFTER PROSTHETIC RESTORATION.

  Patient problems: Failure of Implant

  MAUDE report 16992352 ↗
• InjuryMar 29, 2021Failure 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 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

  MAUDE report 11581164 ↗
• InjuryNov 16, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN AND MOBILITY 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

  MAUDE report 10842694 ↗
• InjuryNov 16, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY 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. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 10842693 ↗
• InjuryJun 27, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INADEQUATE BONE QUALITY/BONE QUANTITY, PAIN, SWELLING, BLEEDING, NUMBNESS, MOBILITY AND FISTULA 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. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Fistula; Numbness; Swelling

  MAUDE report 8738607 ↗
• InjuryMar 19, 2019Failure 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.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8431368 ↗
• InjuryOct 19, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY, PERI-IMPLANTITIS AND ASYMPTOMATIC 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

  MAUDE report 7983349 ↗
• InjuryOct 19, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY, PAIN AND POOR ORAL HYGIENE WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1-5 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 7983329 ↗
• InjuryMay 10, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY, SWELLING, POOR ORAL HYGIENE AND PAIN 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 7504241 ↗
• InjuryMay 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  INFECTION, ASINTOMATICA, BAD ORAL HYGIENE AND PERI-IMPLANTITIS 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 ACHIEVED. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 7490104 ↗
• InjuryJan 9, 2018Failure 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 AND OSSEONTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant

  MAUDE report 7174653 ↗
• InjuryDec 21, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  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

  MAUDE report 7137428 ↗
• InjuryNov 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY AND PAIN 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 AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7027519 ↗
• InjuryNov 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY 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 WAS ACHIEVED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7026000 ↗
• InjuryNov 13, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INFECTION, BLEEDING, SWELLING AND NUMBNESS 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.

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

  MAUDE report 7025989 ↗
• InjuryNov 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PAIN, FISTULA AND INFECTION 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.

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

  MAUDE report 7024616 ↗
• InjuryNov 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  INADEQUATE BONE QUALITY/BONE QUANTITY, MOBILITY, INFECTION, PAIN, BLEEDING, SWELLING, NUMBNESS, PERI-IMPLANTITIS AND FISTULA WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE IV. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1 TO 5 YEARS AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. PATIENT IS A SMOKER.

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

  MAUDE report 7024614 ↗
• InjurySep 5, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BLEEDING, SWELLING, NUMBNESS, FISTULA AND PERI-IMPLANTITIS WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. PATIENT IS A SMOKER AND HAS XEROSTOMIA.

  Patient problems: Failure of Implant; Fistula; Numbness; Swelling

  MAUDE report 6841396 ↗
• InjurySep 5, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BLEEDING, SWELLING, NUMBNESS, FISTULA AND PERI-IMPLANTITIS WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. PATIENT IS A SMOKER AND HAS XEROSTOMIA.

  Patient problems: Failure of Implant; Fistula; Numbness; Swelling

  MAUDE report 6841393 ↗
• InjuryApr 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  BLEEDING AND MOBILITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1-5 YEARS AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PATIENT HAS PERI-IMPLANTITIS.

  Patient problems: Failure of Implant

  MAUDE report 6517035 ↗
• InjuryFeb 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PAIN WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1-5 YRS AFTER FINAL PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. IT WAS ALSO REPORTED FRACTURE OF THE IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 6353367 ↗
• InjuryDec 29, 2016Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 6214365 ↗
• InjuryNov 7, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY AND INFECTION WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS OVER A YEAR AFTER FINAL PROSTHETIC RESTORATION. IT WAS ALSO REPORTED NO OSSEOINTEGRATION OF THE IMPLANT.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 6083432 ↗
• InjuryNov 7, 2016Osseointegration Problem; Osseointegration Problem

  PAIN WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS MORE THAN A YEAR AFTER PROSTHETIC RESTORATION. IT WAS ALSO REPORTED BREAKAGE OF THE IMPLANT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6083387 ↗