miniMark Dental Implant System 10290840 (UDI 00614950003112)Recalls & reported problems
Ace Surgical Supply CO., Inc. · miniMARK 2.9X8.0MM W/4MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI · Class 2 · Implant
All models of miniMark Dental Implant System (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00614950003112), received between Oct 13, 2016 and Nov 11, 2016 — classified as 3 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Osseointegration Problem2
- Fracture1
Patient problems
- Failure of Implant3
- Pain1
- Swelling1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 11, 2016Osseointegration Problem; Osseointegration Problem
MOBILITY AND ASSINTOMATICA WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1 YEAR BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS NOT ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PATIENT IS A SMOKER AND HAS PERI-IMPLANTITIS.
Patient problems: Failure of Implant
MAUDE report 6096628 ↗InjuryOct 13, 2016Fracture
IT WAS REPORTED WHILE TORQUING THE IMPLANT BROKE DURING PLACEMENT AND IMPLANT FRACTURE WAS INVOLVED IN IMPLANT FAILURE. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE III. PATIENT IS A SMOKER AND HAS DIABETES.
Patient problems: Failure of Implant
MAUDE report 6026441 ↗InjuryOct 13, 2016Osseointegration Problem; Osseointegration Problem
PAIN, BLEEDING, SWELLING AND POOR ORAL HYGIENE WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YR PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE III. PATIENT IS A SMOKER AND HAS DIABETES.
Patient problems: Failure of Implant; Pain; Swelling
MAUDE report 6026438 ↗
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- 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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