Infinity External Hex Implant System 404011Recalls & reported problems
Ace Surgical Supply CO., Inc. · INFINITY EXTERNAL 4.0X11.5MM Ø4.0HD HEX IMPLANT TI CP GRADE 4 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
The Infinity External Hex Implant is a root-form dental implant used to anchor replacement teeth in the jawbone. The 38 reports describe implants that failed to fuse properly with surrounding bone, leaving them loose, along with pain, swelling and some infections. There are 38 injuries and no deaths. 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
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00614950005475), received between Dec 1, 2015 and May 10, 2023 — classified as 38 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (28 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 Problem28
- Failure to Osseointegrate7
- Insufficient Device Problem Information7
- Appropriate Device Problem Term/Code Not Available1
- Device Slipped1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant37
- Pain7
- Unspecified Infection2
- Numbness1
- Osteolysis1
- Swelling1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryJan 7, 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 I. 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 HAD DIABETES.
Patient problems: Failure of Implant
MAUDE report 11133515 ↗InjuryAug 1, 2019Failure 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 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 8849803 ↗InjuryAug 1, 2019Failure 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 II. 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 IS A SMOKER.
Patient problems: Failure of Implant
MAUDE report 8849799 ↗InjuryJan 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
PAIN AND INFECTION WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 8278819 ↗InjurySep 28, 2018Failure 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 7919562 ↗InjuryMay 15, 2018Failure 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. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 7513540 ↗InjuryJan 9, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 7174649 ↗InjuryNov 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
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 ACHIEVED.
Patient problems: Failure of Implant; Pain
MAUDE report 7025998 ↗InjuryNov 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
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 1 TO 5 YEARS AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED.
Patient problems: Failure of Implant
MAUDE report 7025997 ↗InjuryNov 13, 2017Failure 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 1 TO 5 YEARS AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED.
Patient problems: Failure of Implant
MAUDE report 7025990 ↗InjurySep 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
PAIN, NUMBNESS, SWELLING AND FISTULA 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. MOBILITY WAS ALSO REPORTED.
Patient problems: Failure of Implant; Numbness; Pain; Swelling
MAUDE report 6839397 ↗InjurySep 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PRIMARY STABILITY WAS NOT ACHIEVED.
Patient problems: Failure of Implant
MAUDE report 6839373 ↗InjuryAug 30, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
ASYMPTOMATIC AND 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.
Patient problems: Failure of Implant
MAUDE report 6829703 ↗InjuryApr 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
MOBILITY, PAIN AND FISTULA WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED.
Patient problems: Failure of Implant; Pain
MAUDE report 6516670 ↗InjuryMar 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
PAIN WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II.
Patient problems: Failure of Implant; Pain
MAUDE report 6375922 ↗InjuryAug 10, 2016Osseointegration Problem; Osseointegration Problem
MOBILITY AND ASSINTOMATICA WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS LESS THAN 1 YEAR AFTER PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF FAILED IMPLANT WAS TYPE III. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED.
Patient problems: Failure of Implant
MAUDE report 5864579 ↗InjuryAug 10, 2016Osseointegration Problem; Osseointegration Problem
MOBILITY AND ASSINTOMATICA WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS LESS THAN 1 YEAR AFTER PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF FAILED IMPLANT WAS TYPE III. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED.
Patient problems: Failure of Implant
MAUDE report 5864578 ↗InjuryAug 10, 2016Osseointegration Problem; Osseointegration Problem
NO OSSEOINTEGRATION OF THE IMPLANT. MOBILITY, INFECTION AND BONE LOSS WAS REPORTED. PATIENT IS A SMOKER.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 5864560 ↗InjuryAug 10, 2016Osseointegration Problem; Osseointegration Problem
NO OSSEOINTEGRATION OF THE IMPLANT. PAIN AND BONE LOSS WAS REPORTED.
Patient problems: Failure of Implant; Pain
MAUDE report 5864547 ↗InjuryAug 10, 2016Osseointegration Problem; Osseointegration Problem
NO OSSEOINTEGRATION OF THE IMPLANT. MOBILITY AND BONE LOSS WAS REPORTED. PATIENT IS A SMOKER.
Patient problems: Failure of Implant
MAUDE report 5864533 ↗InjuryJul 26, 2016Osseointegration Problem; Osseointegration Problem
MOBILITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1-3 MONTHS BEFORE DISCOVERY. NO OSSEOINTEGRATION OF THE IMPLANT. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE III.
Patient problems: Failure of Implant
MAUDE report 5823559 ↗InjuryJul 15, 2016Osseointegration Problem; Osseointegration Problem
MOBILITY AND BONE LOSS 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 5798128 ↗InjuryJul 15, 2016Osseointegration Problem; Osseointegration Problem
NO OSSEOINTEGRATION OF THE IMPLANT WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS (B)(6) MONTHS BEFORE DISCOVERING.
Patient problems: Failure of Implant
MAUDE report 5798108 ↗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 5739646 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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