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LEVEL ONE CMF 25-198-06-61Recalls & reported problems

KLS-Martin L.P. · SCREW, MAXDRIVE, L1 MMF, DRILL FREE, TI-6AL-4V · Class 2 · Implant

All models of LEVEL ONE CMF (150)

Data updated Oct 18, 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 00888118108845), received between Sep 4, 2018 and Feb 26, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Break2

Patient problems

  • Device Embedded In Tissue or Plaque1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • InjuryFeb 26, 2019Break; Break

    IT WAS REPORTED A SCREW BROKE AND ALL PIECES WERE REMOVED FROM PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8370366 ↗
  • InjurySep 4, 2018Break; Break

    IT WAS REPORTED THAT A SCREW BROKE DURING IMPLANTATION. A PORTION OF THE SCREW REMAINED IN THE PATIENT.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 7842153 ↗

Other PLATE, BONE devices

All PLATE, BONE devices →

Sources and updates

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