Infinity Internal Hex System 203710Recalls & reported problems
Ace Surgical Supply CO., Inc. · infinity INTERNAL 3.7x10MM Ø3.5 HEX IMPLANT 6AL-4V ELI · Class 2 · Implant
Quick summary
This ACE Surgical Infinity implant is a root-form implant placed in bone. Its 415 reports mostly describe the implant failing to bond with the bone, and some describe the implant becoming loose or mobile. The reports include no deaths and 415 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
- 415
- Deaths reported
- 0
- Injuries reported
- 415
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 415 adverse event reports that list this exact device (DI 00614950004638), received between Dec 22, 2015 and Jun 3, 2026 — classified as 415 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (322 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 Problem322
- Failure to Osseointegrate310
- Insufficient Device Problem Information27
- Loss of Osseointegration16
- Patient Device Interaction Problem10
- Activation, Positioning or Separation Problem1
- Appropriate Device Problem Term/Code Not Available1
- Device Issue1
Patient problems
- Failure of Implant411
- Pain124
- Unspecified Infection36
- Swelling15
- Fistula9
- Numbness6
- Insufficient Information3
- Patient Problem/Medical Problem1
Recent adverse event reports
The 25 most recent of 415 reports, in the reporter's own words as published by the FDA.
InjuryJun 3, 2026Failure to Osseointegrate
InjuryApr 3, 2026Failure to Osseointegrate
InjuryApr 1, 2026Failure to Osseointegrate
InjuryApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 3, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 7, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJun 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJun 3, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 9, 2024Osseointegration Problem; Osseointegration Problem
IMPLANT LOSS DUE TO POOR HYGEINE AND HEAVY SMOKING.
Patient problems: Failure of Implant
MAUDE report 18475320 ↗InjuryJan 9, 2024Osseointegration Problem; Osseointegration Problem
IMPLANT LOSS DUE TO POOR HYGEINE AND VERY HARD BONE.
Patient problems: Failure of Implant
MAUDE report 18475317 ↗InjuryJan 9, 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
InjuryJan 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS DUE TO POOR HYGIENE AND HEAVY SMOKING.
Patient problems: Failure of Implant
MAUDE report 18447392 ↗
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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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.