Infinity External Hex Implant System 404711Recalls & reported problems
Ace Surgical Supply CO., Inc. · INFINITY EXTERNAL 4.75X11.5MM Ø5.0HD HEX IMPLANT TI CP GRADE 4 · Class 2 · Implant
All models of Infinity External Hex Implant System (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ACE Surgical Infinity dental implant is placed in the jawbone to support a replacement tooth. The 26 reports, all injury reports with no deaths, mostly describe implants that never fused to the bone or later became loose, along with pain and swelling. 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
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00614950005529), received between Dec 1, 2015 and Jun 5, 2024 — classified as 26 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (18 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.
Reports received per month
Most reported problems
Device problems
- Osseointegration Problem18
- Failure to Osseointegrate11
- Insufficient Device Problem Information4
Patient problems
- Failure of Implant26
- Pain7
- Swelling2
- Fistula1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 6, 2023Failure to Osseointegrate; Failure to Osseointegrate
PATIENT NOTICED THE IMPLANT WAS LOOSE WITH NO PAIN. IMPLANT WAS TORQUED PROPERLY AT CEMENTATION WITHOUT PROBLEM OR PAIN.
Patient problems: Failure of Implant
MAUDE report 17273560 ↗InjuryJun 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
INADEQUATE BONE QUALITY/BONE QUANTITY, MOBILITY 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 PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 8738604 ↗InjuryJul 23, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
POOR ORAL HYGIENE 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 1-5 YEARS AFTER 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 7710309 ↗InjuryMay 7, 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 IS A SMOKER.
Patient problems: Failure of Implant
MAUDE report 7490100 ↗InjuryMay 7, 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 IS A SMOKER.
Patient problems: Failure of Implant
MAUDE report 7490092 ↗InjuryJan 9, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
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 7174626 ↗InjuryDec 21, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
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. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 7137548 ↗InjuryDec 20, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
PAIN 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 ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant; Pain
MAUDE report 7135154 ↗InjuryOct 23, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
MOBILITY, PAIN, BLEEDING, SWELLING AND FISTULA WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED.
Patient problems: Failure of Implant; Fistula; Pain; Swelling
MAUDE report 6969800 ↗InjurySep 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
PAIN, SWELLING AND INADEQUATE BONE QUALITY/BONE QUANTITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. PATIENT IS A SMOKER.
Patient problems: Failure of Implant; Pain; Swelling
MAUDE report 6839219 ↗InjuryApr 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
MOBILITY AND ASYMPTOMATIC 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 NOT ACHIEVED. DOCTOR ALSO REPORTED INADEQUATE BONE QUALITY. PATIENT HAS DIABETES AND XEROSTOMIA.
Patient problems: Failure of Implant
MAUDE report 6518168 ↗InjuryMar 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
PAIN WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1 YEAR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II-III.
Patient problems: Failure of Implant; Pain
MAUDE report 6419151 ↗InjuryDec 14, 2016Osseointegration Problem; Osseointegration Problem
MOBILITY AND PAIN WAS REPORTED. NO OSSEOINTEGRATION OF THE IMPLANT 1-3 MONTHS AFTER FINAL RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT SURGERY TYPE III. PATIENT IS A SMOKER.
Patient problems: Failure of Implant; Pain
MAUDE report 6173270 ↗InjuryNov 7, 2016Osseointegration Problem; Osseointegration Problem
MOBILITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS OVER A YEAR AFTER FINAL PROSTHETIC RESTORATION. IT WAS ALSO REPORTED NO OSSEOINTEGRATION OF THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 6083421 ↗InjuryNov 7, 2016Osseointegration Problem; Osseointegration Problem
MOBILITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS OVER A YEAR AFTER FINAL PROSTHETIC RESTORATION. IT WAS ALSO REPORTED NO OSSEOINTEGRATION OF THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 6083412 ↗InjuryJul 26, 2016Osseointegration Problem; Osseointegration Problem
MOBILITY, PAIN AND SCAR TISSUE WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 3-6 MONTHS BEFORE DISCOVERY. NO OSSEOINTEGRATION OF THE IMPLANT. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE II.
Patient problems: Failure of Implant
MAUDE report 5823573 ↗InjuryJul 15, 2016Osseointegration Problem; Osseointegration Problem
MOBILITY AND PAIN WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS MORE THAN A YEAR AFTER FINAL RESTORATION. NO OSSEOINTEGRATION OF THE IMPLANT.
Patient problems: Failure of Implant; Pain
MAUDE report 5798144 ↗InjuryJun 21, 2016Osseointegration Problem; Osseointegration Problem
MOBILITY WAS 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
MAUDE report 5739941 ↗InjuryMar 28, 2016Osseointegration Problem; Osseointegration Problem
MOBILITY WAS REPORTED. NO OSSEOINTEGRATION. 1-3 MONTHS BEFORE DISCOVERY.
Patient problems: Failure of Implant
MAUDE report 5528914 ↗InjuryMar 28, 2016Osseointegration Problem; Osseointegration Problem
PAIN AND INFECTION WAS REPORTED. NO OSSEOINTEGRATION. AFTER FINAL RESTORATION MORE THAN 1 YEAR.
Patient problems: Failure of Implant
MAUDE report 5528728 ↗InjuryDec 28, 2015Failure to Osseointegrate
InjuryDec 15, 2015Osseointegration Problem
PAIN WAS REPORTED AT THE TIME OF IMPLANT FAILURE.
Patient problems: Failure of Implant
MAUDE report 5297486 ↗InjuryDec 15, 2015Osseointegration Problem
MOBILITY WAS REPORTED AT THE TIME OF IMPLANT FAILURE. NO OSSEOINTEGRATION AFTER 6 MONTHS OF FINAL DENTAL RESTORATION.
Patient problems: Failure of Implant
MAUDE report 5297345 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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