MIS UNO MO1-16300Recalls & reported problems
MIS Implants Technologies Ltd. · Uno one piece implant dia. 3 L 16mm · Class 2 · Implant
All models of MIS UNO (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07290108996050), received between Aug 25, 2024 and Feb 13, 2025 — classified as 14 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (8 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Osseointegration Problem8
- Failure to Osseointegrate6
Patient problems
- Failure of Implant14
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryFeb 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21372850 ↗InjuryFeb 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21372846 ↗InjuryFeb 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21354680 ↗InjuryFeb 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21340843 ↗InjuryFeb 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21340837 ↗InjuryFeb 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21308467 ↗InjurySep 20, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. LESS THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20264577 ↗InjurySep 18, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. DAY OF SURGERY/0-4 WEEKS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20246699 ↗InjurySep 18, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. DAY OF SURGERY/0-4 WEEKS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20246678 ↗InjurySep 5, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THAN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20144908 ↗InjuryAug 27, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. LESS THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20073139 ↗InjuryAug 27, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. LESS THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20073135 ↗InjuryAug 25, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20060796 ↗InjuryAug 25, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. LESS THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20059418 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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