miniMark Dental Implant System 09270705Recalls & reported problems
Ace Surgical Supply CO., Inc. · miniMARK BALL 1.8/2.3 X 15MM 2MM CUFF RBM IMPLANT W/KEEPER · 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00614950002887), received between Feb 26, 2016 and Nov 29, 2016 — classified as 4 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (4 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 Problem4
Patient problems
- Failure of Implant4
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 29, 2016Osseointegration Problem
DOCTOR STATES THE IMPLANT STOPS WITHIN THE BONE. HE ALSO STATES PART OF THE IMPLANT BURIED IN THE BONE IS NOT EXTRUDED.
Patient problems: Failure of Implant
MAUDE report 6133379 ↗InjuryNov 28, 2016Osseointegration Problem; Osseointegration Problem
MOBILITY, PAIN AND BONE BREAK WAS REPORTED. NO OSSEOINTEGRATION OF THE IMPLANT 1-3 MONTHS BEFORE DISCOVERY. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II.
Patient problems: Failure of Implant; Pain
MAUDE report 6130126 ↗InjuryFeb 26, 2016Osseointegration Problem; Osseointegration Problem
MOBILITY WAS REPORTED. NO OSSEOINTEGRATION 0-1 MONTHS BEFORE DISCOVERY.
Patient problems: Failure of Implant
MAUDE report 5462791 ↗InjuryFeb 26, 2016Osseointegration Problem; Osseointegration Problem
TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 0-1 MONTHS AFTER PROSTHETIC RESTORATION. MOBILITY AND BONE LOSS WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 5462790 ↗
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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 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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