Infinity Internal Hex System 205110Recalls & reported problems
Ace Surgical Supply CO., Inc. · infinity INTERNAL 5.1x10.0MM Ø4.5HD HEX IMPLANT 6AL-4V ELI · Class 2 · Implant
All models of Infinity Internal Hex System (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ACE Surgical Infinity internal hex implant is a small endosseous dental implant used as a tooth root replacement. The 67 reports describe implants that fail to fuse properly with the surrounding bone, leaving them loose or "spinning," often with pain, swelling, or infection at the site; no deaths were reported. 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
- 67
- Deaths reported
- 0
- Injuries reported
- 67
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00614950004805), received between Feb 10, 2016 and Jun 6, 2025 — classified as 67 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (43 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 Problem43
- Failure to Osseointegrate36
- Insufficient Device Problem Information8
- Loss of Osseointegration5
- Patient Device Interaction Problem3
- Therapeutic or Diagnostic Output Failure2
- Device Issue1
- Missing Value Reason1
Patient problems
- Failure of Implant67
- Pain8
- Unspecified Infection8
- Fistula3
- Swelling2
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2025Loss of Osseointegration; Loss of Osseointegration
IMPLANT #30 SPINNED WITH SLIGHT INFECTION.
Patient problems: Failure of Implant
MAUDE report 22158953 ↗InjuryApr 30, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 12, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 12, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 12, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 8, 2023Osseointegration Problem; Osseointegration Problem
InjurySep 7, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 27, 2023Loss of Osseointegration; Loss of Osseointegration
TOOTH #3 SPINED AND SLIGHT INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 17409130 ↗InjuryJul 13, 2023Failure to Osseointegrate; Failure to Osseointegrate
#14 JUST SPINNED AND SLIGHT INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 17317641 ↗InjuryJun 5, 2023Failure to Osseointegrate; Failure to Osseointegrate
TOOTH #3 SITE IMPLANT LOOSE AND SLIGHT INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 17063076 ↗InjuryMay 25, 2023Osseointegration Problem; Patient Device Interaction Problem; Osseointegration Problem; Patient Device Interaction Problem
InjuryMay 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
#4 REMOVED DUE TO INFECTION AND LOOSE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 16974234 ↗InjuryApr 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT #3 JUST SPINNED AND SLIGHT INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 16763447 ↗InjuryApr 3, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryFeb 24, 2023Osseointegration Problem; Osseointegration Problem
InjuryDec 22, 2021Therapeutic or Diagnostic Output Failure
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. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. MOBILITY WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 13059871 ↗InjuryDec 22, 2021Therapeutic or Diagnostic Output Failure
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. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. MOBILITY AND FISTULA WERE REPORTED.
Patient problems: Failure of Implant; Fistula
MAUDE report 13059870 ↗InjuryOct 18, 2021Failure 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 12647545 ↗InjuryApr 22, 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 III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR 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 11711814 ↗InjuryOct 28, 2020Failure to Osseointegrate; Failure to Osseointegrate
DENTIST DECIDED TO USE A BIGGER IMPLANT. 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 10750197 ↗InjuryOct 25, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
INADEQUATE BONE QUALITY/BONE QUANTITY, PAIN AND BLEEDING 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 problems: Failure of Implant; Pain
MAUDE report 9241277 ↗InjuryJul 16, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
PAIN, LACK OF OSSEOINTEGRATION AND BLEEDING 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 8792498 ↗InjuryJun 27, 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 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 8738603 ↗InjuryJun 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ASYMPTOMATIC AND MOBILITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE IV. 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 8715603 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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