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MIS M4 MF4-13330Recalls & reported problems

MIS Implants Technologies Ltd. · M4 internal hex. implant dia. 3.30 L 13mm, NP · Class 2 · Implant

Quick summary

This MIS M4 dental implant has 138 adverse event reports, with no deaths and 138 injuries. Most describe the implant being lost or failing to fuse with the bone. No recalls name this device. Reports fell to 18 over the last year from 94 in the year before.

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
139
Deaths reported
0
Injuries reported
139
Recalls naming it
0

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 07290108991796), received between Aug 22, 2024 and Sep 17, 2026 — classified as 139 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (93 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: 1 reportsSep 2024: 20 reportsOct 2024: 5 reportsNov 2024: 14 reportsDec 2024: 6 reportsJan 2025: 4 reportsFeb 2025: 36 reportsMar 2025: 9 reportsApr 2025: 7 reportsMay 2025: 1 reportsJun 2025: 10 reportsJul 2025: 0 reportsAug 2025: 3 reportsSep 2025: 1 reportsOct 2025: 3 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 11 reportsFeb 2026: 3 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 2 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports20242025202636
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate93
  • Osseointegration Problem45
  • Loss of Osseointegration1

Patient problems

  • Failure of Implant138
  • No Clinical Signs, Symptoms or Conditions1
  • Unspecified Infection1

Recent adverse event reports

The 25 most recent of 139 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 50805278 ↗
  • InjuryJun 26, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH A SINUS INFECTION AFFECTING THE RIGHT SIDE OF THE MAXILLA.

    Patient problems: Failure of Implant; Unspecified Infection

    MAUDE report 25638430 ↗
  • InjuryJun 22, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 25577363 ↗
  • InjuryMar 30, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24720530 ↗
  • InjuryFeb 3, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24252512 ↗
  • InjuryFeb 3, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24251068 ↗
  • InjuryFeb 2, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24234582 ↗
  • InjuryJan 27, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24193749 ↗
  • InjuryJan 26, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24176164 ↗
  • InjuryJan 26, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24176159 ↗
  • InjuryJan 23, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24163252 ↗
  • InjuryJan 23, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24163057 ↗
  • InjuryJan 22, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24157634 ↗
  • InjuryJan 14, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24071717 ↗
  • InjuryJan 12, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24048725 ↗
  • InjuryJan 9, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 24027250 ↗
  • InjuryJan 7, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 23999852 ↗
  • InjuryJan 5, 2026Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 23969425 ↗
  • InjuryDec 10, 2025Failure to Osseointegrate; Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 23774510 ↗
  • InjuryOct 25, 2025Failure to Osseointegrate; Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 23386836 ↗
  • InjuryOct 25, 2025Failure to Osseointegrate; Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 23386770 ↗
  • InjuryOct 25, 2025Failure to Osseointegrate; Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 23386765 ↗
  • InjurySep 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 23008831 ↗
  • InjuryAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 22898574 ↗
  • InjuryAug 7, 2025Failure to Osseointegrate; Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 22744495 ↗

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.