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MIS M4 MF4-11420Recalls & reported problems

MIS Implants Technologies Ltd. · M4 internal hex. implant dia. 4.20 L 11.50mm · Class 2 · Implant

Quick summary

This MIS M4 dental implant is anchored in the jawbone. Most of the 587 reports describe the implant failing to fuse with the bone or being lost, and reports fell from 355 in the previous 12 months to 66 in the latest 12 months. The reports include 587 injuries and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
593
Deaths reported
0
Injuries reported
593
Recalls naming it
0

Summary

The FDA's MAUDE database contains 593 adverse event reports that list this exact device (DI 07290108991703), received between Aug 13, 2024 and Sep 17, 2026 — classified as 593 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (308 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 20 reportsSep 2024: 79 reportsOct 2024: 67 reportsNov 2024: 79 reportsDec 2024: 53 reportsJan 2025: 27 reportsFeb 2025: 57 reportsMar 2025: 45 reportsApr 2025: 8 reportsMay 2025: 9 reportsJun 2025: 35 reportsJul 2025: 7 reportsAug 2025: 23 reportsSep 2025: 1 reportsOct 2025: 11 reportsNov 2025: 5 reportsDec 2025: 12 reportsJan 2026: 12 reportsFeb 2026: 5 reportsMar 2026: 7 reportsApr 2026: 2 reportsMay 2026: 7 reportsJun 2026: 7 reportsJul 2026: 4 reportsAug 2026: 5 reportsSep 2026: 6 reportsOct 2026: 0 reports20242025202679
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate308
  • Osseointegration Problem279
  • Loss of Osseointegration6

Patient problems

  • Failure of Implant587
  • No Clinical Signs, Symptoms or Conditions4
  • Inadequate Osseointegration2

Recent adverse event reports

The 25 most recent of 593 reports, in the reporter's own words as published by the FDA.

  • InjurySep 17, 2026Loss of Osseointegration

    It was reported that a patient experienced a dental implant loss.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50806661 ↗
  • InjurySep 17, 2026Loss of Osseointegration

    It was reported that a patient experienced a dental implant loss.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50803594 ↗
  • InjurySep 17, 2026Loss of Osseointegration

    It was reported that a patient experienced a dental implant loss.

    Patient problems: Inadequate Osseointegration

    MAUDE report 50800368 ↗
  • InjurySep 11, 2026Loss of Osseointegration

    It was reported that a patient experienced a dental implant loss. There was no reported injury.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50734004 ↗
  • InjurySep 11, 2026Loss of Osseointegration

    It was reported that a patient experienced a dental implant loss. There was no reported injury.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50733956 ↗
  • InjurySep 10, 2026Loss of Osseointegration

    It was reported that a patient experienced a dental implant loss.

    Patient problems: Inadequate Osseointegration

    MAUDE report 50717973 ↗
  • InjuryAug 13, 2026Failure to Osseointegrate

    It was reported that a patient experienced a dental implant loss.

    Patient problems: Failure of Implant

    MAUDE report 50245190 ↗
  • InjuryAug 13, 2026Failure to Osseointegrate

    It was reported that a patient experienced a dental implant loss.

    Patient problems: Failure of Implant

    MAUDE report 50245189 ↗
  • InjuryAug 13, 2026Failure to Osseointegrate

    It was reported that a patient experienced a dental implant loss.

    Patient problems: Failure of Implant

    MAUDE report 50245188 ↗
  • InjuryAug 13, 2026Failure to Osseointegrate

    It was reported that a patient experienced a dental implant loss.

    Patient problems: Failure of Implant

    MAUDE report 50245187 ↗
  • InjuryAug 13, 2026Failure to Osseointegrate

    It was reported that a patient experienced a dental implant loss.

    Patient problems: Failure of Implant

    MAUDE report 50241258 ↗
  • InjuryJul 27, 2026Failure to Osseointegrate

    It was reported that a patient experienced a dental implant loss due to a post-surgical infection.

    Patient problems: Failure of Implant

    MAUDE report 50035761 ↗
  • InjuryJul 27, 2026Failure to Osseointegrate

    It was reported that a patient experienced a dental implant loss.

    Patient problems: Failure of Implant

    MAUDE report 50035563 ↗
  • InjuryJul 27, 2026Failure to Osseointegrate

    It was reported that a patient experienced a dental implant loss.

    Patient problems: Failure of Implant

    MAUDE report 50035483 ↗
  • InjuryJul 9, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 25765521 ↗
  • InjuryJun 23, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 25596256 ↗
  • InjuryJun 23, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 25596235 ↗
  • InjuryJun 22, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 25577251 ↗
  • InjuryJun 19, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 25568354 ↗
  • InjuryJun 19, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 25568353 ↗
  • InjuryJun 16, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FAILURE.

    Patient problems: Failure of Implant

    MAUDE report 25526961 ↗
  • InjuryJun 16, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FAILURE.

    Patient problems: Failure of Implant

    MAUDE report 25526932 ↗
  • InjuryMay 28, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 25314505 ↗
  • InjuryMay 27, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FAILURE.

    Patient problems: Failure of Implant

    MAUDE report 25306660 ↗
  • InjuryMay 15, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FAILURE.

    Patient problems: Failure of Implant

    MAUDE report 25191650 ↗

Other Implant, Endosseous, Root-Form devices

All Implant, Endosseous, Root-Form devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.