Infinity Internal Hex System 203708Recalls & reported problems
Ace Surgical Supply CO., Inc. · infinity INTERNAL 3.7x8.0MM Ø3.5HD HEX IMPLANT 6AL-4V ELI · Class 2 · Implant
Quick summary
This ACE Surgical Infinity internal hex dental implant has 139 adverse event reports, with no deaths and 139 injuries. Most describe the implant failing to fuse with the bone, with some reports citing poor bone quality, smoking or hygiene, and others describing mobility or mild infection. 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
- 139
- Deaths reported
- 0
- Injuries reported
- 139
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 00614950004621), received between Dec 22, 2015 and Jun 27, 2025 — classified as 139 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (109 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 Problem109
- Failure to Osseointegrate99
- Insufficient Device Problem Information12
- Loss of Osseointegration9
- Patient Device Interaction Problem2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Device Issue1
Patient problems
- Failure of Implant139
- Pain37
- Unspecified Infection9
- Swelling8
- Numbness7
- Fistula3
Recent adverse event reports
The 25 most recent of 139 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 5, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMay 20, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryApr 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT WAS SPININING AND SLIGHT INFECTION.
Patient problems: Failure of Implant
MAUDE report 19023289 ↗InjuryJan 9, 2024Osseointegration Problem; Osseointegration Problem
IMPLANT LOSS DUE TO POOR HYGEINE AND HEAVY SMOKING
Patient problems: Failure of Implant
MAUDE report 18475803 ↗InjuryJan 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION AND SLIGHT INFECTION.
Patient problems: Failure of Implant
MAUDE report 17969577 ↗InjuryAug 11, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 10, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 8, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2023Loss of Osseointegration; Loss of Osseointegration
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 NOT ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. MOBILITY WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 13059851 ↗InjuryOct 21, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PERI-IMPLANTITIS AND MOBILITY 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 (ALLOGRAFT) WAS PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 12677155 ↗InjuryOct 4, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
PAIN, BLEEDING, SWELLING, 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; Unspecified Infection
MAUDE report 12567733 ↗InjuryOct 4, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
MOBILITY, INFECTION 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 IS A SMOKER.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 12567713 ↗InjuryJul 21, 2021Failure 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 AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 12201846 ↗InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem
BONE QUALITY WAS NOT IDENTIFIED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS NOT IDENTIFIED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS NOT ACHIEVED AT SURGERY. OSSEOINTEGRATION AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 11913601 ↗InjuryJun 1, 2021Failure to Osseointegrate
BONE QUALITY WAS NOT IDENTIFIED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED AT THE TIME OF SURGERY BUT IMPLANT DID NOT INTEGRATE WITH BONE AT RESTORATION. OSSEOINTEGRATION AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 11913475 ↗InjuryApr 22, 2021Failure 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 AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 11711803 ↗InjuryApr 22, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
INADEQUATE BONE QUALITY/BONE QUANTITY 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 PROCEDURE WAS PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 11711794 ↗InjuryMar 29, 2021Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PAIN AND BLEEDING WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1 TO 5 YEARS 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; Pain
MAUDE report 11581168 ↗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 IS A SMOKER.
Patient problems: Failure of Implant
MAUDE report 11423156 ↗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 IS A SMOKER.
Patient problems: Failure of Implant
MAUDE report 11423149 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.