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MIS M4Recalls & reported problems across all models

MIS Implants Technologies Ltd. · 26 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
7,602
Deaths reported
0
Injuries reported
7,602
Recalls
0

We found 26 models of MIS M4 by MIS Implants Technologies Ltd. in the FDA's device registry (GUDID). Together they are named in 7,602 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2024 and Sep 30, 2026 — classified as 7,602 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (3,990 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

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: 249 reportsSep 2024: 1,011 reportsOct 2024: 733 reportsNov 2024: 1,072 reportsDec 2024: 602 reportsJan 2025: 357 reportsFeb 2025: 811 reportsMar 2025: 425 reportsApr 2025: 85 reportsMay 2025: 99 reportsJun 2025: 476 reportsJul 2025: 155 reportsAug 2025: 263 reportsSep 2025: 68 reportsOct 2025: 98 reportsNov 2025: 86 reportsDec 2025: 144 reportsJan 2026: 238 reportsFeb 2026: 171 reportsMar 2026: 85 reportsApr 2026: 28 reportsMay 2026: 50 reportsJun 2026: 86 reportsJul 2026: 68 reportsAug 2026: 54 reportsSep 2026: 88 reportsOct 2026: 0 reports2024202520261,072
Last 36 months. The most recent month may be incomplete.

Most reported MIS M4 problems

Device problems

  • Failure to Osseointegrate3,990
  • Osseointegration Problem3,534
  • Loss of Osseointegration76
  • Fracture3

Patient problems

  • Failure of Implant7,513
  • No Clinical Signs, Symptoms or Conditions68
  • Inadequate Osseointegration20
  • Inflammation5
  • Insufficient Information2
  • Osteolysis2
  • Unspecified Infection2
  • Implant Pain1

MIS M4 models

26 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent MIS M4 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other MIS Implants Technologies Ltd. products

All MIS Implants Technologies Ltd. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page