MIS M4 MF4-16500Recalls & reported problems
MIS Implants Technologies Ltd. · M4 internal hex. implant dia. 5 L 16mm · Class 2 · Implant
All models of MIS M4 (26)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07290108991604), received between Sep 2, 2024 and Jun 14, 2025 — classified as 8 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate4
- Osseointegration Problem4
Patient problems
- Failure of Implant8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22208283 ↗InjuryFeb 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21322803 ↗InjuryFeb 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21321715 ↗InjuryJan 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21270457 ↗InjuryNov 14, 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 20682388 ↗InjuryNov 14, 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 20682349 ↗InjurySep 2, 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 20116196 ↗InjurySep 2, 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 20116168 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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