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MIS M4 MF4-08375Recalls & reported problems

MIS Implants Technologies Ltd. · M4 internal hex. implant dia.3.75 L 8mm · Class 2 · Implant

Quick summary

This MIS M4 dental implant has 770 FDA reports, all of them injury reports, and no deaths. Most reports describe the implant failing to bond with the jawbone or losing that bond, with patients losing the implant. There are no recalls naming this device. Reports fell from 480 in the previous 12 months to 88 in the most recent 12 months.

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
775
Deaths reported
0
Injuries reported
775
Recalls naming it
0

Summary

The FDA's MAUDE database contains 775 adverse event reports that list this exact device (DI 07290108991536), received between Aug 13, 2024 and Sep 17, 2026 — classified as 775 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (397 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: 24 reportsSep 2024: 94 reportsOct 2024: 84 reportsNov 2024: 126 reportsDec 2024: 80 reportsJan 2025: 32 reportsFeb 2025: 67 reportsMar 2025: 39 reportsApr 2025: 10 reportsMay 2025: 11 reportsJun 2025: 50 reportsJul 2025: 26 reportsAug 2025: 26 reportsSep 2025: 5 reportsOct 2025: 8 reportsNov 2025: 5 reportsDec 2025: 10 reportsJan 2026: 34 reportsFeb 2026: 11 reportsMar 2026: 5 reportsApr 2026: 3 reportsMay 2026: 3 reportsJun 2026: 7 reportsJul 2026: 8 reportsAug 2026: 2 reportsSep 2026: 5 reportsOct 2026: 0 reports202420252026126
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Osseointegration Problem397
  • Failure to Osseointegrate373
  • Loss of Osseointegration5

Patient problems

  • Failure of Implant770
  • No Clinical Signs, Symptoms or Conditions4
  • Inadequate Osseointegration1

Recent adverse event reports

The 25 most recent of 775 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; no osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50800576 ↗
  • 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 50800494 ↗
  • 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 50800357 ↗
  • InjurySep 16, 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 50787856 ↗
  • InjurySep 14, 2026Loss of Osseointegration

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

    Patient problems: Inadequate Osseointegration

    MAUDE report 50753042 ↗
  • InjuryAug 11, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 50203502 ↗
  • InjuryAug 10, 2026Failure to Osseointegrate

    It was reported that a patient experienced dental implant loss due to fibrointegration.

    Patient problems: Failure of Implant

    MAUDE report 50196662 ↗
  • InjuryJul 29, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 50072901 ↗
  • InjuryJul 29, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 50068099 ↗
  • InjuryJul 29, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 50068088 ↗
  • InjuryJul 28, 2026Failure to Osseointegrate

    It was reported that a patient experienced dental implant loss. Osseointegration failure was observed.

    Patient problems: Failure of Implant

    MAUDE report 50057692 ↗
  • InjuryJul 27, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 50035440 ↗
  • InjuryJul 10, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25788816 ↗
  • InjuryJul 9, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25765640 ↗
  • InjuryJul 8, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25752220 ↗
  • InjuryJun 29, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25650484 ↗
  • InjuryJun 19, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25560601 ↗
  • InjuryJun 19, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25560510 ↗
  • InjuryJun 17, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS; 2 IMPLANTS INVOLVED.

    Patient problems: Failure of Implant

    MAUDE report 25541088 ↗
  • InjuryJun 17, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS; 2 IMPLANTS INVOLVED.

    Patient problems: Failure of Implant

    MAUDE report 25541035 ↗
  • InjuryJun 17, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25530741 ↗
  • InjuryJun 5, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25406224 ↗
  • InjuryMay 28, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25314336 ↗
  • InjuryMay 6, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25104954 ↗
  • InjuryMay 5, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25088413 ↗

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.