Infinity Internal Hex System 204108Recalls & reported problems
Ace Surgical Supply CO., Inc. · infinity INTERNAL 4.1x8.0MM Ø3.5HD HEX IMPLANT 6AL-4V ELI · Class 2 · Implant
Quick summary
This ACE Surgical infinity internal hex implant is a root-form dental implant placed into bone. Its 152 adverse event reports are all listed as injuries, with no deaths, and most describe implants that failed to fuse with bone or were lost, sometimes linked to poor bone quality. Other reports mention pain, infection and an implant dropping during surgery. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 152
- Deaths reported
- 0
- Injuries reported
- 152
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 00614950004683), received between Nov 24, 2015 and Jun 2, 2026 — classified as 152 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (122 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.
Reports received per month
Most reported problems
Device problems
- Osseointegration Problem122
- Failure to Osseointegrate116
- Insufficient Device Problem Information8
- Loss of Osseointegration5
- Device Issue2
- Appropriate Device Problem Term/Code Not Available1
- No Apparent Adverse Event1
- Output Problem1
Patient problems
- Failure of Implant150
- Pain40
- Unspecified Infection19
- Numbness3
- Swelling2
- Fistula1
- Insufficient Information1
- Limited Mobility Of The Implanted Joint1
Recent adverse event reports
The 25 most recent of 152 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2026Failure to Osseointegrate; No Apparent Adverse Event
InjuryJun 5, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMay 20, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMay 20, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMay 20, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION AND SLIGHT INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 17969563 ↗InjuryAug 9, 2023Loss of Osseointegration; Loss of Osseointegration
MOBILITY AFTER 1 YEAR & PATIENT LOST IT DIRECTLY.
Patient problems: Failure of Implant
MAUDE report 17494319 ↗InjuryJul 24, 2023Osseointegration Problem; Osseointegration Problem
INADEQUATE BONE TYPE AND NON-REGULAR HYGEINE.
Patient problems: Failure of Implant
MAUDE report 17385095 ↗InjuryApr 27, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 5, 2022Output Problem
BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO ONE YEAR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. MOBILITY AND PROVISIONAL PROSTHESIS WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 13170335 ↗InjuryJan 5, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 5, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 5, 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 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 12575475 ↗InjuryOct 4, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
MOBILITY, NOT ENOUGH BONE AND INADEQUATE BONE QUALITY/BONE QUANTITY 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 12567732 ↗InjuryOct 4, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
MOBILITY, PAIN AND INADEQUATE BONE QUALITY/BONE QUANTITY 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 12567708 ↗InjuryOct 4, 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 IS A SMOKER.
Patient problems: Failure of Implant
MAUDE report 12567701 ↗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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE (ALLOGRAFT) WAS PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 12417801 ↗InjuryJul 21, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
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 ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 12201842 ↗InjuryJun 10, 2021Failure to Osseointegrate
INFECTION 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 AND OSSEOINTEGRATION WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 11975525 ↗InjuryJun 1, 2021Unstable; Failure to Osseointegrate
BONE QUALITY WAS TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS NOT ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS PERFORMED AT THE TIME OF SURGERY (BONE GRAFT AND 1 COLLAGEN PLUG).
Patient problems: Failure of Implant
MAUDE report 11915323 ↗InjuryMay 28, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
BONE QUALITY WAS TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS NOT ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT TIME OF SURGERY. DR USED WRONG SIZE.
Patient problems: Failure of Implant
MAUDE report 11904111 ↗InjuryApr 22, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
MOBILITY, 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 IS A SMOKER.
Patient problems: Failure of Implant; Pain
MAUDE report 11711800 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.