Infinity External Hex Implant System 404008Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00614950005451), received between Dec 1, 2015 and Jan 7, 2021 — classified as 24 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Failure of Implant; Fistula; Numbness; Pain; Swelling/ Edema

  MAUDE report 11133485 ↗
• InjuryApr 24, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN AND MOBILITY 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. OSSEOINTEGRATION WAS NOT ACHIEVED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 9995515 ↗
• InjuryMay 15, 2018Failure 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 WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 7513539 ↗
• InjuryMay 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY, SWELLING, POOR ORAL HYGIENE, BONE LOSS AND PAIN 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. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant; Swelling

  MAUDE report 7504246 ↗
• InjuryApr 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PAIN, BLEEDING, SWELLING, NUMBNESS, FISTULA, MOBILITY AND ASINTOMATICA 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. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

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

  MAUDE report 7464462 ↗
• InjuryJan 9, 2018Failure 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 7174648 ↗
• InjuryJan 8, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  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 7171116 ↗
• InjuryDec 21, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 7137553 ↗
• InjuryDec 21, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  NUMBNESS, ASINTOMATICA 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 HAS DIABETES.

  Patient problems: Failure of Implant; Fistula; Numbness

  MAUDE report 7137430 ↗
• InjuryDec 21, 2017Device Issue; Osseointegration Problem; Device Issue; 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; Fistula; Numbness; Swelling

  MAUDE report 7137427 ↗
• InjuryDec 21, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BLEEDING, PAIN, SWELLING, NUMBNESS, ASINTOMATICA AND FISTULA WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE I. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. PATIENT IS A SMOKER.

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

  MAUDE report 7137423 ↗
• InjuryMar 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY WAS 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 II.

  Patient problems: Failure of Implant

  MAUDE report 6419141 ↗
• InjuryMar 3, 2017Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant

  MAUDE report 6375914 ↗
• InjuryFeb 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  BLEEDING, SWELLING, NUMBNESS, FISTULA WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1 YR AFTER FINAL PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PATIENT HAS DIABETES MELLITUS, ALLERGIES AND BLOOD CLOTTING DISORDER.

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

  MAUDE report 6353436 ↗
• InjuryFeb 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  BLEEDING, SWELLING, NUMBNESS, FISTULA AND ASYMPTOMATIC WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1 YR AFTER FINAL RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. IT WAS ALSO REPORTED DISCOMFORT AND MOBILITY AFTER A MONTH OF PROSTHETIC RESTORATION.

  Patient problems: Failure of Implant; Numbness; Swelling

  MAUDE report 6353419 ↗
• InjuryNov 11, 2016Osseointegration Problem; Osseointegration Problem

  TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. IT WAS REPORTED NO OSSEOINTEGRATION.

  Patient problems: Failure of Implant

  MAUDE report 6096539 ↗
• InjuryJul 5, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY AND NO OSSEOINTEGRATION WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1-3 MONTHS BEFORE DISCOVERY. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS NORMAL.

  Patient problems: Failure of Implant

  MAUDE report 5770007 ↗
• InjuryJul 5, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY AND NO OSSEOINTEGRATION WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III.

  Patient problems: Failure of Implant

  MAUDE report 5770006 ↗
• InjuryMar 28, 2016Osseointegration Problem; Osseointegration Problem

  NO INFORMATION PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 5529046 ↗
• InjuryMar 28, 2016Osseointegration Problem; Osseointegration Problem

  BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE IV. PRIMARY STABILITY WAS NOT ACHIEVED.

  Patient problems: Failure of Implant

  MAUDE report 5528749 ↗
• InjuryMar 8, 2016Osseointegration Problem; Osseointegration Problem

  BONE QUALITY AT THE TIME OF FAILED IMPLANT WAS TYPE II. PRIMARY STABILITY WAS ACHIEVED BUT OSSEOINTEGRATION WAS NOT. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant

  MAUDE report 5487031 ↗
• InjuryMar 8, 2016Osseointegration Problem; Osseointegration Problem

  BONE QUALITY AT THE TIME OF FAILED IMPLANT WAS TYPE II. MOBILITY WAS REPORTED. PRIMARY STABILITY WAS ACHIEVED BUT OSSEOINTEGRATED WAS NOT. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant

  MAUDE report 5487026 ↗
• InjuryDec 1, 2015Osseointegration Problem

  IMPLANT FAILURE DUE TO MOBILITY. BONE QUALITY AT TIME OF FAILURE WAS REPORTED AS TYPE II.

  Patient problems: Failure of Implant

  MAUDE report 5257384 ↗
• InjuryDec 1, 2015Osseointegration Problem

  MOBILITY WAS REPORTED AT THE TIME OF IMPLANT FAILURE

  Patient problems: Failure of Implant

  MAUDE report 5257383 ↗