Infinity Internal Hex System 205108Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00614950004799), received between Dec 28, 2015 and Jun 9, 2026 — classified as 54 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (44 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 54 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Failure to Osseointegrate

  IMPLANT FAILED TO OSSEOINTEGRATE.

  Patient problems: Insufficient Information

  MAUDE report 25449708 ↗
• InjuryOct 12, 2023Failure to Osseointegrate; Failure to Osseointegrate

  NO OSSEOINTEGRATION.

  Patient problems: Failure of Implant

  MAUDE report 17927398 ↗
• InjuryAug 11, 2023Loss of Osseointegration; Loss of Osseointegration

  POOR BONE QUALITY.

  Patient problems: Failure of Implant

  MAUDE report 17513688 ↗
• InjuryJul 25, 2023Failure to Osseointegrate; Failure to Osseointegrate

  NO INTEGRATION.

  Patient problems: Failure of Implant

  MAUDE report 17393369 ↗
• InjuryJun 22, 2023Loss of Osseointegration; Loss of Osseointegration

  AFTER 3 WEEKS IMPLANT JUST SPINNED AND SLIGHT INFECTION #30.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 17187163 ↗
• InjuryOct 4, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY, NUMBNESS AND INADEQUATE BONE QUALITY/BONE QUANTITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Numbness

  MAUDE report 12567671 ↗
• InjurySep 2, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY 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 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 12417834 ↗
• InjurySep 2, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY 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 BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE (ALLOGRAFT) WAS PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 12417828 ↗
• InjuryAug 6, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MOBILITY AND PERI-IMPLANTITIS WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1 TO 5 YEARS AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE (ALLOGRAFT) WAS PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 12290902 ↗
• InjuryMar 29, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INFECTION, INFLAMMATION AND MOBILITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 11581041 ↗
• InjuryMar 29, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INFECTION, PAIN, INCREASED SENSITIVITY AND MOBILITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER AND ALLERGIC TO PENICILLIN.

  Patient problems: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 11581038 ↗
• InjuryMar 5, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INADEQUATE BONE QUALITY/BONE QUANTITY AND PAIN 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; Pain

  MAUDE report 11423185 ↗
• InjuryMar 5, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INADEQUATE BONE QUALITY/BONE QUALITY AND MOBILITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. 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 problems: Failure of Implant

  MAUDE report 11423178 ↗
• InjuryMar 3, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INADEQUATE BONE QUALITY/BONE QUANTITY 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 problems: Failure of Implant

  MAUDE report 11404045 ↗
• InjuryJan 14, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INADEQUATE BONE QUALITY/BONE QUANTITY AND MOBILITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION PROCEDURE WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant

  MAUDE report 11171377 ↗
• InjuryJul 21, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INADEQUATE BONE QUALITY/BONE QUANTITY 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

  MAUDE report 10301206 ↗
• InjuryMay 7, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 10032715 ↗
• InjuryMay 7, 2020Failure 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 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 problems: Failure of Implant

  MAUDE report 10032710 ↗
• InjuryApr 2, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INADEQUATE BONE QUALITY/BONE QUANTITY AND MOBILITY 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 problems: Failure of Implant

  MAUDE report 9916866 ↗
• InjuryApr 2, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INADEQUATE BONE QUALITY/BONE QUANTITY, NUMBNESS, FISTULA AND MOBILITY 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 problems: Failure of Implant; Numbness

  MAUDE report 9916861 ↗
• InjuryFeb 24, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE (ALLOGRAFT) WAS PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 9743934 ↗
• InjuryJan 31, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  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.

  Patient problems: Failure of Implant

  MAUDE report 9655300 ↗
• InjuryNov 18, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY AND INADEQUATE BONE QUALITY/BONE QUANTITY 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

  MAUDE report 9334175 ↗
• InjuryOct 25, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INADEQUATE BONE QUALITY/BONE QUANTITY, BLEEDING 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 9241275 ↗
• InjuryJul 16, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN, LACK OF OSSEOINTEGRATION AND BLEEDING 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

  MAUDE report 8792494 ↗