Infinity External Hex Implant System 404010Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00614950005468), received between Dec 1, 2015 and May 22, 2023 — classified as 28 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (23 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2023Failure to Osseointegrate; Osseointegration Problem; Patient Device Interaction Problem; Failure to Osseointegrate; Osseointegration Problem; Patient Device Interaction Problem

  FAILED TO OSTEOINTERGRATE.

  Patient problems: Failure of Implant

  MAUDE report 16979588 ↗
• 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 9995489 ↗
• InjuryNov 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INADEQUATE BONE QUALITY/BONE QUANTITY, BLEEDING AND SWELLING WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE (ALLOGRAFT) WAS PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 9330670 ↗
• InjuryMar 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

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

  MAUDE report 8431389 ↗
• InjuryMar 19, 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 problems: Failure of Implant

  MAUDE report 8431367 ↗
• InjuryNov 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Failure of Implant; Pain; Swelling

  MAUDE report 8073110 ↗
• InjuryOct 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY, PAIN, 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 AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT HAS DIABETES.

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

  MAUDE report 8014285 ↗
• InjuryAug 14, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INFECTION WAS 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 problems: Failure of Implant; Unspecified Infection

  MAUDE report 7780673 ↗
• InjuryJan 9, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN AND NUMBNESS 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; Numbness; Pain

  MAUDE report 7174646 ↗
• InjuryDec 20, 2017Failure 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 AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7135143 ↗
• InjuryNov 13, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INFECTION 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 OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT TIME OF SURGERY. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 7025994 ↗
• InjuryApr 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY AND INFECTION WAS REPORTED. PRIMARY STABILITY WAS ACHIEVED. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 6516129 ↗
• InjuryMar 20, 2017Osseointegration Problem; Osseointegration Problem

  PAIN, BLEEDING, NUMBNESS, SWELLING AND ASINTOMATICA WAS 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 III. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant; Pain; Swelling

  MAUDE report 6418751 ↗
• InjuryNov 11, 2016Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED NO OSSEOINTEGRATION OF THE IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 6096638 ↗
• InjuryNov 7, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. 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

  MAUDE report 6083425 ↗
• InjuryJul 5, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY AND NO OSSEOINTEGRATION WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 0-3 MONTHS BEFORE DISCOVERY. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III.

  Patient problems: Failure of Implant

  MAUDE report 5770010 ↗
• InjuryJul 5, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE FINAL RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. BONE LOSS WAS ALSO REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 5769991 ↗
• InjuryJun 21, 2016Osseointegration Problem; 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.

  Patient problems: Failure of Implant

  MAUDE report 5739945 ↗
• InjuryJun 21, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS MORE THAN A YEAR AFTER FINAL RESTORATION.

  Patient problems: Failure of Implant

  MAUDE report 5739657 ↗
• InjuryJun 21, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS AFTER FINAL RESTORATION.

  Patient problems: Failure of Implant

  MAUDE report 5739651 ↗
• InjuryJun 17, 2016Osseointegration Problem; Osseointegration Problem

  PAIN AND MOBILITY WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS LESS THAN 1 YEAR AFTER THE PLACEMENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 5732466 ↗
• InjuryJun 17, 2016Osseointegration Problem; Osseointegration Problem

  PAIN WAS REPORTED. NO OSTEOINTEGRATION IN 3-6 MONTHS.

  Patient problems: Failure of Implant; Pain

  MAUDE report 5732276 ↗
• InjuryJun 2, 2016Osseointegration Problem; Osseointegration Problem

  ASYMPTOMATIC 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 ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. CUSTOMER STATES THE IMPLANT FAILED.

  Patient problems: Failure of Implant

  MAUDE report 5695378 ↗
• InjuryMar 28, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY, INFECTION AND PAIN WAS REPORTED. BONE DENSITY WAS 1-3 MONTHS. NO OSSEOINTEGRATION AND BONE LOSS WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 5529039 ↗
• InjuryDec 22, 2015Osseointegration Problem

  PRIMARY STABILIZATION WAS ACHIEVED. NO OSSEOINTEGRATION WAS ALSO REPORTED. SOME INCREASE IN BONE MASS WAS CARRIED OUT. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE II.

  Patient problems: Failure of Implant

  MAUDE report 5318358 ↗