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MIS M4 MF4-08500Recalls & reported problems

MIS Implants Technologies Ltd. · M4 internal hex. implant dia. 5 L 8mm · Class 2 · Implant

Quick summary

This MIS M4 dental implant has 206 adverse event reports: no deaths and 206 injuries. Reports describe the implant failing to bond with the jawbone, and many say the patient lost the implant. Reports fell to 40 in the last 12 months from 134 in the previous 12. 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
213
Deaths reported
0
Injuries reported
213
Recalls naming it
0

Summary

The FDA's MAUDE database contains 213 adverse event reports that list this exact device (DI 07290108991598), received between Aug 25, 2024 and Sep 30, 2026 — classified as 213 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (143 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: 2 reportsSep 2024: 19 reportsOct 2024: 11 reportsNov 2024: 25 reportsDec 2024: 9 reportsJan 2025: 7 reportsFeb 2025: 28 reportsMar 2025: 19 reportsApr 2025: 5 reportsMay 2025: 2 reportsJun 2025: 10 reportsJul 2025: 14 reportsAug 2025: 12 reportsSep 2025: 1 reportsOct 2025: 2 reportsNov 2025: 5 reportsDec 2025: 6 reportsJan 2026: 7 reportsFeb 2026: 6 reportsMar 2026: 2 reportsApr 2026: 3 reportsMay 2026: 0 reportsJun 2026: 7 reportsJul 2026: 2 reportsAug 2026: 2 reportsSep 2026: 7 reportsOct 2026: 0 reports20242025202628
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate143
  • Osseointegration Problem65
  • Loss of Osseointegration5

Patient problems

  • Failure of Implant206
  • No Clinical Signs, Symptoms or Conditions7
  • Inflammation1

Recent adverse event reports

The 25 most recent of 213 reports, in the reporter's own words as published by the FDA.

  • InjurySep 30, 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 50944504 ↗
  • InjurySep 14, 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 50756188 ↗
  • InjurySep 14, 2026Failure to Osseointegrate

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50754248 ↗
  • InjurySep 14, 2026Failure to Osseointegrate

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50754241 ↗
  • InjurySep 12, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50745583 ↗
  • InjurySep 11, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50740092 ↗
  • 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 50736656 ↗
  • InjuryAug 13, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 50233454 ↗
  • InjuryAug 6, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant; Inflammation

    MAUDE report 50155464 ↗
  • InjuryJul 16, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25840087 ↗
  • InjuryJul 15, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25831302 ↗
  • InjuryJun 29, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25649917 ↗
  • InjuryJun 17, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25537193 ↗
  • InjuryJun 17, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25537189 ↗
  • InjuryJun 17, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25537182 ↗
  • InjuryJun 17, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25537180 ↗
  • InjuryJun 17, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25537178 ↗
  • InjuryJun 17, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25537173 ↗
  • InjuryApr 14, 2026Failure to Osseointegrate

    CUSTOMER REPORTED IMPLANT FAILURE.

    Patient problems: Failure of Implant

    MAUDE report 24879771 ↗
  • InjuryApr 8, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24820323 ↗
  • InjuryApr 2, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24770085 ↗
  • InjuryMar 3, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24498250 ↗
  • InjuryMar 3, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24498163 ↗
  • InjuryFeb 18, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24381832 ↗
  • InjuryFeb 16, 2026Failure to Osseointegrate

    MIS WARRANTY. COSTUMER REPORTED IMPLANT FAILURE. (B)(4).

    Patient problems: Failure of Implant

    MAUDE report 24358475 ↗

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.