Infinity Internal Hex System 204710Recalls & reported problems
Ace Surgical Supply CO., Inc. · infinity INTERNAL 4.7x10MM Ø4.5HD HEX IMPLANT 6AL-4V ELI · Class 2 · Implant
Quick summary
This ACE Surgical Infinity implant is a device placed into bone. The 236 reports mostly describe the implant failing to fuse with the bone or becoming loose or spinning, and some report pain, infection or implant loss tied to poor bone quality. The reports include 236 injuries and no deaths. 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
- 236
- Deaths reported
- 0
- Injuries reported
- 236
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 236 adverse event reports that list this exact device (DI 00614950004744), received between Dec 1, 2015 and Apr 30, 2025 — classified as 236 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (180 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 Problem180
- Failure to Osseointegrate162
- Insufficient Device Problem Information17
- Loss of Osseointegration9
- Patient Device Interaction Problem7
- Device Issue1
- Output Problem1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Failure of Implant236
- Pain64
- Unspecified Infection23
- Swelling9
- Fistula7
- Numbness7
- Swelling/ Edema2
Recent adverse event reports
The 25 most recent of 236 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryFeb 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 3, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJun 3, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
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
InjuryDec 11, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 11, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 8, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION AND SLIGHT INFECTION.
Patient problems: Failure of Implant
MAUDE report 17970006 ↗InjuryOct 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION AND SLIGHT INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 17969566 ↗InjuryOct 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION AND SLIGHT INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 17969565 ↗InjurySep 8, 2023Osseointegration Problem; Osseointegration Problem
InjuryAug 23, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 11, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 9, 2023Loss of Osseointegration; Loss of Osseointegration
PAIN & MOBILITY AT 1.5 YEARS POST. POOR BONE QUALITY FOUND UPON REMOVAL.
Patient problems: Failure of Implant; Pain
MAUDE report 17494313 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.