Infinity External Hex Implant SystemRecalls & reported problems across all models
Ace Surgical Supply CO., Inc. · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 297
- Deaths reported
- 0
- Injuries reported
- 297
- Recalls
- 0
We found 16 models of Infinity External Hex Implant System by Ace Surgical Supply CO., Inc. in the FDA's device registry (GUDID). Together they are named in 297 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2015 and Jun 5, 2024 — classified as 297 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (228 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Infinity External Hex Implant System problems
Device problems
- Osseointegration Problem228
- Failure to Osseointegrate100
- Insufficient Device Problem Information54
- Appropriate Device Problem Term/Code Not Available3
- Device Issue3
- Loss of Osseointegration3
- Patient Device Interaction Problem2
- Device Slipped1
Patient problems
- Failure of Implant292
- Pain79
- Swelling39
- Unspecified Infection34
- Numbness31
- Fistula29
- Inadequate Osseointegration1
- Inflammation1
Infinity External Hex Implant System models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Infinity External Hex Implant System 403711IMPLANT, ENDOSSEOUS, ROOT-FORM44 reports
- Infinity External Hex Implant System 404011IMPLANT, ENDOSSEOUS, ROOT-FORM38 reports
- Infinity External Hex Implant System 403710IMPLANT, ENDOSSEOUS, ROOT-FORM34 reports
- Infinity External Hex Implant System 404010IMPLANT, ENDOSSEOUS, ROOT-FORM28 reports
- Infinity External Hex Implant System 404711IMPLANT, ENDOSSEOUS, ROOT-FORM26 reports
- Infinity External Hex Implant System 404008IMPLANT, ENDOSSEOUS, ROOT-FORM24 reports
- Infinity External Hex Implant System 404013IMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- Infinity External Hex Implant System 404710IMPLANT, ENDOSSEOUS, ROOT-FORM15 reports
- Infinity External Hex Implant System 404708IMPLANT, ENDOSSEOUS, ROOT-FORM13 reports
- Infinity External Hex Implant System 403311IMPLANT, ENDOSSEOUS, ROOT-FORM12 reports
- Infinity External Hex Implant System 403708IMPLANT, ENDOSSEOUS, ROOT-FORM12 reports
- Infinity External Hex Implant System 403713IMPLANT, ENDOSSEOUS, ROOT-FORM11 reports
- Infinity External Hex Implant System 403310IMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
- Infinity External Hex Implant System 404713IMPLANT, ENDOSSEOUS, ROOT-FORM9 reports
- Infinity External Hex Implant System 403308IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Infinity External Hex Implant System 403313IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent Infinity External Hex Implant System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 4, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJul 6, 2023Failure to Osseointegrate; Failure to Osseointegrate
PATIENT NOTICED THE IMPLANT WAS LOOSE WITH NO PAIN. IMPLANT WAS TORQUED PROPERLY AT CEMENTATION WITHOUT PROBLEM OR PAIN.
Patient problems: Failure of Implant
MAUDE report 17273560 ↗InjuryMay 24, 2023Osseointegration Problem; Osseointegration Problem
TIME OF LOSS IN RELATION TO THE IMPLEMENTATION WAS 1 TO 5 YEARS AFTER PROSTHETIC RESTORATION.
Patient problems: Failure of Implant
MAUDE report 16992352 ↗InjuryMay 22, 2023Failure to Osseointegrate; Osseointegration Problem; Patient Device Interaction Problem; Failure to Osseointegrate; Osseointegration Problem; Patient Device Interaction Problem
InjuryMay 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryJul 30, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
MOBILITY, OVERHEATING OF BONE AND INADEQUATE BONE QUALITY/BONE QUANTITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE I. 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 IS AN EX-SMOKER.
Patient problems: Failure of Implant
MAUDE report 12254146 ↗InjuryMar 29, 2021Failure 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 IV. 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 11581164 ↗InjuryMar 29, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
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 11581161 ↗InjuryMar 29, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
MOBILITY 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. PATIENT IS A SMOKER.
Patient problems: Failure of Implant
MAUDE report 11581160 ↗InjuryJan 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
MOBILITY WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE I. 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 HAD DIABETES.
Patient problems: Failure of Implant
MAUDE report 11133515 ↗InjuryJan 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PAIN, BLEEDING, SWELLING, NUMBNESS, MOBILITY AND FISTULA 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 ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant; Fistula; Numbness; Pain; Swelling/ Edema
MAUDE report 11133485 ↗InjuryNov 16, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
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 IS A SMOKER.
Patient problems: Failure of Implant
MAUDE report 10842696 ↗InjuryNov 16, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
PAIN AND MOBILITY 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 AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 10842694 ↗
Other Ace Surgical Supply CO., Inc. products
All Ace Surgical Supply CO., Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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