Infinity Internal Hex System 203711Recalls & reported problems
Ace Surgical Supply CO., Inc. · infinity INTERNAL 3.7x11.5MM Ø3.5HD HEX IMPLANT 6AL-4V ELI · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ACE Surgical Infinity dental implant is a screw-shaped implant placed in the jawbone to support a replacement tooth. Of the 161 reports, many describe implants that failed to bond with the bone or became loose, and some describe infection or numbness. The reports include no deaths and 161 injuries. 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
- 161
- Deaths reported
- 0
- Injuries reported
- 161
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 00614950004645), received between Dec 28, 2015 and Apr 1, 2026 — classified as 161 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (127 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 Problem127
- Failure to Osseointegrate124
- Insufficient Device Problem Information12
- Patient Device Interaction Problem7
- Loss of Osseointegration2
- Therapeutic or Diagnostic Output Failure2
Patient problems
- Failure of Implant159
- Pain38
- Unspecified Infection12
- Numbness9
- Fistula7
- Swelling4
- Inadequate Osseointegration1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 161 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2026Failure to Osseointegrate
InjuryFeb 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 20, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJan 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS DUE TO POOR BONE QUALITY AND POOR HYGIENE.
Patient problems: Failure of Implant
MAUDE report 18447442 ↗InjuryMay 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMay 23, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 23, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED TO INTEGRATE.
Patient problems: Failure of Implant; Swelling/ Edema
MAUDE report 16983647 ↗InjuryMay 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMay 10, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryJan 5, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 22, 2021Failure to Osseointegrate; Therapeutic or Diagnostic Output Failure
BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO ONE YEAR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PAIN WAS REPORTED.
Patient problems: Failure of Implant; Pain
MAUDE report 13059862 ↗InjuryDec 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
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 WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 13059853 ↗InjuryDec 22, 2021Therapeutic or Diagnostic Output Failure
BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO ONE TO FIVE YEARS AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. MOBILITY WAS REPORTED.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 13059849 ↗InjuryOct 19, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
PAIN AND SWELLING WERE 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant; Pain
MAUDE report 12657218 ↗InjuryOct 4, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
MOBILITY, FISTULA 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 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 12567717 ↗InjurySep 2, 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 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 12417819 ↗InjuryJul 29, 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 II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE (ALLOGRAFT) WAS PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 12246482 ↗InjuryJun 21, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
MOBILITY AND IMPLANT FRACTURE 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 (ALLOGRAFT) WAS PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 12035299 ↗InjuryJun 9, 2021Failure to Osseointegrate; Patient Device Interaction Problem; Failure to Osseointegrate; Patient Device Interaction Problem
SWELLING AND BLEEDING WERE REPORTED. BONE QUALITY WAS IDENTIFIED AS TYPE I. 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 TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 11967260 ↗InjuryJun 9, 2021Failure to Osseointegrate; Patient Device Interaction Problem; Failure to Osseointegrate; Patient Device Interaction Problem
SWELLING AND BLEEDING WERE REPORTED. BONE QUALITY WAS IDENTIFIED AS TYPE I. 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 TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 11967242 ↗InjuryMay 28, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
BONE QUALITY WAS TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS NOT ACHIEVED AT SURGERY. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS PERFORMED AT THE TIME OF SURGERY (ALLOGRAFT).
Patient problems: Failure of Implant
MAUDE report 11904165 ↗InjuryApr 22, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
XEROSTOMIA 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 11711824 ↗InjuryApr 22, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
MOBILITY, PAIN, BLEEDING 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 11711810 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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