Infinity Internal Hex System 204106Recalls & reported problems
Ace Surgical Supply CO., Inc. · infinity INTERNAL 4.1x6.0MM Ø3.5HD HEX IMPLANT 6AL-4V ELI · Class 2 · Implant
Quick summary
This ACE Surgical Infinity Internal Hex implant has 85 reports in the FDA database, with no deaths and 85 injuries. Most reports describe the implant failing to integrate with the bone, and several mention poor bone quality or a lack of initial stability. 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
- 85
- Deaths reported
- 0
- Injuries reported
- 85
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00614950004676), received between Jan 11, 2016 and Aug 21, 2023 — classified as 85 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (61 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
Device problems
- Osseointegration Problem61
- Failure to Osseointegrate58
- Loss of Osseointegration10
- Insufficient Device Problem Information5
- Patient Device Interaction Problem2
- Appropriate Device Problem Term/Code Not Available1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Failure of Implant84
- Pain18
- Fistula5
- Numbness5
- Unspecified Infection5
- Swelling2
- Limited Mobility Of The Implanted Joint1
Recent adverse event reports
The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 10, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 10, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 9, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 8, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 7, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 2, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 2, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 1, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 31, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 27, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryJul 24, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryJun 30, 2023Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
InjuryMay 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryDec 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
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. PAIN, BLEEDING AND NUMBNESS WERE REPORTED.
Patient problems: Failure of Implant; Pain
MAUDE report 13059858 ↗InjuryDec 22, 2021Failure to Osseointegrate; Therapeutic or Diagnostic Output Failure
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. PAIN, BLEEDING, AND NUMBNESS WERE REPORTED.
Patient problems: Failure of Implant; Pain
MAUDE report 13059857 ↗InjuryJul 21, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
MOBILITY WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II AND 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 12201850 ↗InjuryApr 22, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
PAIN, BLEEDING, MOBILITY, INFECTION 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 11711817 ↗InjuryApr 22, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
FISTULA, PERI-IMPLANTITIS, 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 AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT HAD RADIATION TX-HEAD/NECK AREA.
Patient problems: Failure of Implant; Fistula
MAUDE report 11711806 ↗InjuryApr 22, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
FISTULA, PERI-IMPLANTITIS, 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant; Fistula
MAUDE report 11711786 ↗InjuryApr 22, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
FISTULA, PERI-IMPLANTITIS, 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 WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant; Fistula
MAUDE report 11711772 ↗InjuryMar 5, 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 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 11423211 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.