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LEVEL ONE CMF 25-875-09-91Recalls & reported problems

KLS-Martin L.P. · SCREW, MAXDRIVE, TI-6AL-4V · Class 2 · Implant

All models of LEVEL ONE CMF (150)

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

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888118047458), received between Jul 12, 2018 and Jun 19, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1
  • Osseointegration Problem1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • Impaired Healing1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 19, 2020Osseointegration Problem; Osseointegration Problem

    IT WAS REPORTED THAT SCREWS BECAME LOOSE AND WERE REMOVED.

    Patient problems: Impaired Healing

    MAUDE report 10174540 ↗
  • InjuryJul 12, 2018Break; Break

    IT WAS REPORTED THE HEAD OF A SCREW BROKE OFF AND A PORTION REMAINED IMPLANTED.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 7681637 ↗

Other PLATE, BONE devices

All PLATE, BONE devices →

Sources and updates

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