Infinity Internal Hex System 204110Recalls & reported problems
Ace Surgical Supply CO., Inc. · infinity INTERNAL 4.1x10MM 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 placed in the jawbone. Most of its 329 reports describe implants that failed to bond with the bone, and some describe implants that became loose, spun in place, or developed a slight infection. The reports include no deaths and 329 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
- 329
- Deaths reported
- 0
- Injuries reported
- 329
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 329 adverse event reports that list this exact device (DI 00614950004690), received between Dec 23, 2015 and Aug 7, 2025 — classified as 329 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (261 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 Problem261
- Failure to Osseointegrate217
- Insufficient Device Problem Information17
- Loss of Osseointegration17
- Patient Device Interaction Problem6
- Adverse Event Without Identified Device or Use Problem1
- Loose or Intermittent Connection1
- Output Problem1
Patient problems
- Failure of Implant326
- Pain98
- Unspecified Infection29
- Swelling11
- Numbness9
- Fistula8
- Patient Problem/Medical Problem2
- No Information1
Recent adverse event reports
The 25 most recent of 329 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 6, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 13, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 13, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJun 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 3, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJun 3, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMay 20, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMay 20, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMay 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 30, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
AFTER 3 MONTHS, SLIGHT INFECTION AND MOBILITY.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 18222621 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- 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 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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