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LEVEL ONE CMF 25-310-85-91Recalls & reported problems

KLS-Martin L.P. · PLATE, MICRO, L SHP, LEFT, 1.5 MM SCREW, CP TITANIUM · 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 00888118038654), received between Oct 13, 2017 and Dec 1, 2022 — 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 18, 2026.

Most reported problems

Device problems

  • Break1
  • Fracture1
  • Osseointegration Problem1

Patient problems

  • Impaired Healing1
  • Inadequate Osseointegration1

Recent adverse event reports

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

  • InjuryDec 1, 2022Break; Break

    IT WAS REPORTED THAT A PLATE BROKE DUE TO POSSIBLE PATIENT NON-COMPLIANCE. IT WAS REMOVED AND REPLACED.

    Patient problems: Impaired Healing

    MAUDE report 15900163 ↗
  • InjuryOct 13, 2017Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

    ON POST-OPERATIVE FOLLOW-UP SURGEON NOTICED BITE WAS OFF AND MAXILLA MOBILE, SECOND SURGERY WAS PERFORMED AND HARDWARE WAS EXPLANTED. UPON EXAMINATION ONE OF THE FOUR PLATES WAS DETERMINED TO BE FRACTURED.

    Patient problems: Inadequate Osseointegration

    MAUDE report 6948801 ↗

Other PLATE, BONE devices

All PLATE, BONE devices →

Sources and updates

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