Infinity External Hex Implant System 403710Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00614950005413), received between Dec 1, 2015 and Nov 8, 2020 — classified as 34 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (21 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 34 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BLOOD CLOTTING DISORDER, PAIN, BLEEDING, NUMBNESS, FISTULA, ASYMPTOMATIC 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 problems: Failure of Implant

  MAUDE report 10806306 ↗
• InjuryJan 3, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BONE QUALITY AT THE IMPLANT FAILURE TYPE III. MOBILITY, PAIN, BLEEDING, SWELLING, ASYMPTOMATIC AND INADEQUATE BONE QUALITY/QUANTITY WERE REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS PERFORMED AT THE TIME OF SURGERY. PATIENT HAS DIABETES.

  Patient problems: Failure of Implant; Pain; Swelling

  MAUDE report 9543635 ↗
• InjuryNov 18, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PAIN, BLEEDING, SWELLING, NUMBNESS, MOBILITY AND FISTULA WERE 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; Fistula; Numbness; Pain; Swelling

  MAUDE report 9335297 ↗
• InjuryJan 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  XEROSTOMIA, BLEEDING, NUMBNESS, FISTULA, ASYMPTOMATIC 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 ACHIEVED.

  Patient problems: Failure of Implant; Fistula; Numbness

  MAUDE report 8278814 ↗
• InjurySep 28, 2018Insufficient 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 AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 7919560 ↗
• InjuryMay 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PAIN, BLEEDING 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 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 7538665 ↗
• InjuryMay 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Failure of Implant; Fistula

  MAUDE report 7504243 ↗
• InjuryMay 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  INFECTION, ASYMPTOMATIC, PERI-IMPLANTITIS 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 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; Unspecified Infection

  MAUDE report 7490044 ↗
• InjuryApr 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PERI-IMPLANTITIS, SWELLING AND NUMBNESS WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE IV. 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 IS A SMOKER.

  Patient problems: Failure of Implant; Numbness; Swelling

  MAUDE report 7464461 ↗
• InjuryApr 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PERI-IMPLANTITIS, SWELLING AND NUMBNESS WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE IV. 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 IS A SMOKER.

  Patient problems: Failure of Implant; Numbness; Swelling

  MAUDE report 7464443 ↗
• InjuryDec 21, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  ASSINTOMATICA WAS 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.

  Patient problems: Failure of Implant

  MAUDE report 7137415 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INFECTION 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED.

  Patient problems: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 7019595 ↗
• InjuryOct 16, 2017Device Issue; Osseointegration Problem; Device Issue; Osseointegration Problem

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

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

  MAUDE report 6951932 ↗
• InjuryOct 16, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PAIN, BLEEDING, SWELLING, NUMBNESS, MOBILITY AND FISTULA WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1-5 YEARS AFTER PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT TIME OF SURGERY.

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

  MAUDE report 6950988 ↗
• InjurySep 6, 2017Loss of Osseointegration; Loss of Osseointegration

  BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE IV. 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 IS A SMOKER.

  Patient problems: Failure of Implant

  MAUDE report 6844484 ↗
• InjurySep 5, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BLEEDING, SWELLING, FISTULA, PERI-IMPLANTITIS AND NUMBNESS. BONE QUALITY AT THE 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. DOCTOR ALSO REPORTED TOOTH WAS SENSITIVE.

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

  MAUDE report 6841450 ↗
• InjurySep 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY WAS 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 AND OSSEOINTEGRATION WAS ACHIEVED.

  Patient problems: Failure of Implant

  MAUDE report 6839378 ↗
• InjuryApr 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  INFLAMMATION WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. NO OTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 6516663 ↗
• InjuryMar 24, 2017Osseointegration Problem; Osseointegration Problem

  PAIN AND MOBILITY WERE REPORTED. PRIMARY STABILITY WAS ACHIEVED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6432575 ↗
• InjuryMar 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PAIN WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6430296 ↗
• InjuryJan 31, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE DISCOVERY. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III.

  Patient problems: Failure of Implant

  MAUDE report 6290243 ↗
• InjuryNov 7, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 3-6 MONTHS BEFORE PROSTHETIC RESTORATION. IT WAS ALSO REPORTED NO OSSEOINTEGRATION OF THE IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 6083336 ↗
• InjuryAug 25, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY, INFECTION AND PAIN WAS REPORTED. NO OSSEOINTEGRATION OF THE IMPLANT 3-6 MONTHS BEFORE DISCOVERY. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 5904339 ↗
• InjuryAug 10, 2016Osseointegration Problem; Osseointegration Problem

  INFECTION, GRANULOMA AND PAIN WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 5864570 ↗
• InjuryAug 10, 2016Device Issue; Osseointegration Problem; Device Issue; Osseointegration Problem

  NO OSSEOINTEGRATION OF THE IMPLANT AFTER FINAL RESTORATION. INFECTION AND BONE LOSS WAS REPORTED.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 5864537 ↗